Multivitamins with Minerals/Folic Acid/Iron/Docusate

Pronunciation: muhl-tee-VYE-ta-mins/MIN-er-als/FOE-lik AS-id/EYE-urn/DOK-ue-sate
Generic Name: Multivitamins with Minerals/Folic Acid/Iron/Docusate
Brand Name: Examples include Glutofac-MX and Hemax

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call a doctor or poison control center right away.

Multivitamins with Minerals/Folic Acid/Iron/Docusate is used for:

Treating or preventing low levels of vitamins, folic acid, iron, and minerals in the body. It may also be used for other conditions as determined by your doctor.

Multivitamins with Minerals/Folic Acid/Iron/Docusate is a vitamin, folic acid, iron, mineral, and stool softener combination. It works by providing extra vitamins, folic acid, iron, and minerals to the body when you need more than what you get in your diet. The stool softener helps prevent constipation that may occur with iron products.

Do NOT use Multivitamins with Minerals/Folic Acid/Iron/Docusate if:

• you are allergic to any ingredient in Multivitamins with Minerals/Folic Acid/Iron/Docusate


• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Multivitamins with Minerals/Folic Acid/Iron/Docusate:

Some medical conditions may interact with Multivitamins with Minerals/Folic Acid/Iron/Docusate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), certain blood disorders (eg, hemolytic or pernicious anemia, porphyria cutanea tarda, thalassemia), or a peptic ulcer


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Multivitamins with Minerals/Folic Acid/Iron/Docusate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) or fluorouracil because the risk of their side effects may be increased by Multivitamins with Minerals/Folic Acid/Iron/Docusate


• Hydantoins (eg, phenytoin), levodopa, mycophenolate, or penicillamine because their effectiveness may be decreased by Multivitamins with Minerals/Folic Acid/Iron/Docusate


• Many prescription and nonprescription medicines (eg, used for infections, heart problems, high blood pressure, immune system suppression, cancer, low blood platelets, osteoporosis, thyroid problems, bladder problems, Parkinson disease, psoriasis, swelling, and other conditions) may interact with Multivitamins with Minerals/Folic Acid/Iron/Docusate. This may increase the risk of side effects or decrease the effectiveness of your other medicines. Ask your doctor or pharmacist if any medicines you take may interact with Multivitamins with Minerals/Folic Acid/Iron/Docusate and how to take them with Multivitamins with Minerals/Folic Acid/Iron/Docusate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Multivitamins with Minerals/Folic Acid/Iron/Docusate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Multivitamins with Minerals/Folic Acid/Iron/Docusate:

Use Multivitamins with Minerals/Folic Acid/Iron/Docusate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Multivitamins with Minerals/Folic Acid/Iron/Docusate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Multivitamins with Minerals/Folic Acid/Iron/Docusate with a full glass of water (8 oz/240 mL).


• Do not take an antacid within 1 hour before or 2 hours after you take Multivitamins with Minerals/Folic Acid/Iron/Docusate.


• Avoid taking Multivitamins with Minerals/Folic Acid/Iron/Docusate with dairy products; they may interfere with the absorption of the iron in Multivitamins with Minerals/Folic Acid/Iron/Docusate.


• If you miss a dose of Multivitamins with Minerals/Folic Acid/Iron/Docusate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Multivitamins with Minerals/Folic Acid/Iron/Docusate.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Multivitamins with Minerals/Folic Acid/Iron/Docusate unless your doctor tells you to.


• Multivitamins with Minerals/Folic Acid/Iron/Docusate may discolor the stools. This is normal and not a cause for concern.


• Multivitamins with Minerals/Folic Acid/Iron/Docusate has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Tell your doctor or dentist that you take Multivitamins with Minerals/Folic Acid/Iron/Docusate before you receive any medical or dental care, emergency care, or surgery.


• Multivitamins with Minerals/Folic Acid/Iron/Docusate has pyridoxine (vitamin B₆), iron, and folic acid in it. Before you start any new medicine, check the label to see if it has pyridoxine, iron, or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Multivitamins with Minerals/Folic Acid/Iron/Docusate while you are pregnant. Multivitamins with Minerals/Folic Acid/Iron/Docusate is found in breast milk. If you are or will be breast-feeding while you use Multivitamins with Minerals/Folic Acid/Iron/Docusate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Multivitamins with Minerals/Folic Acid/Iron/Docusate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; persistent nausea, vomiting, or diarrhea; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizures; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of Multivitamins with Minerals/Folic Acid/Iron/Docusate:

Store Multivitamins with Minerals/Folic Acid/Iron/Docusate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Multivitamins with Minerals/Folic Acid/Iron/Docusate out of the reach of children and away from pets.

General information:

• If you have any questions about Multivitamins with Minerals/Folic Acid/Iron/Docusate, please talk with your doctor, pharmacist, or other health care provider.


• Multivitamins with Minerals/Folic Acid/Iron/Docusate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Multivitamins with Minerals/Folic Acid/Iron/Docusate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Multivitamins with Minerals/Folic Acid/Iron/Docusate resources

• Multivitamins with Minerals/Folic Acid/Iron/Docusate Use in Pregnancy & Breastfeeding
• Multivitamins with Minerals/Folic Acid/Iron/Docusate Drug Interactions
• Multivitamins with Minerals/Folic Acid/Iron/Docusate Support Group
• 4 Reviews for Multivitamins with Minerals/Folic Acid/Iron/Docusate - Add your own review/rating

Compare Multivitamins with Minerals/Folic Acid/Iron/Docusate with other medications

• Vitamin/Mineral Supplementation and Deficiency

Multi Vitamin Tablets Chewable

Dosage Form: tablet, chewable
Unknown Title

Multi-Vitamin With Fluoride Chewable Tablets

Rx Only

*Daily Value not established
Supplement Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet	% Daily Value Adults & children 4 years or more
Vitamin A .................................. 2500 IU	50%
Vitamin C ..................................... 60 mg	100%
Vitamin D .................................... 400 IU	100%
Vitamin E ...................................... 15 IU	50%
Thiamin (B1) ............................ 1.05 mg	70%
Riboflavin (B2) ........................... 1.2 mg	71%
Niacin ....................................... 13.5 mg	68%
Vitamin (B6) ............................. 1.05 mg	53%
Folate ......................................... 0.3 mg	75%
Vitamin B12 .............................. 4.5 mcg	75%
Fluoride (as sodium fluoride) ... 0.50 mg	*

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cherry flavor, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C Red #40 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

• If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.


• All sources of fluoride should be evaluated with a thorough fluoride history.


• Patient exposure to multiple water sources can make proper prescribing complex.


• Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.


• Fluoride supplements require long-term compliance on a daily basis.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION

*1.0 ppm = 1 mg / liter
**2.2 mg Sodium Fluoride contains 1mg fluoride ion.
Fluoride Ion Level in Drinking Water (ppm)*
AGE	<0.3 ppm	0.3-0.6 ppm	>0.6 ppm
4-6 years	0.50 mg / day**(1 tablet)	0.25 mg / day(1/2 tablet)	None
6-16 years	1.0 mg / day(2 tablets)	0.50 mg / day(1 tablet)	None

HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for: Boca Pharmacal, Inc.

Coral Springs, FL 33065 www.bocapharmacal.com

1-800-354-8460 Iss. 08/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 12]

MULTI-VITAMIN  vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, alpha-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-814 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 0.50 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug

Inactive Ingredients Ingredient Name Strength RIBOFLAVIN   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C RED NO. 40   FOLIC ACID   GELATIN   SODIUM ASCORBATE   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   PYRIDOXINE   .ALPHA.-TOCOPHEROL, DL-   SODIUM CITRATE   SILICON DIOXIDE   THIAMINE   VITAMIN A ACETATE   ASCORBIC ACID   SUCRALOSE   BUTYLATED HYDROXYTOLUENE   .ALPHA.-TOCOPHEROL ACETATE   CHERRY, UNSPECIFIED   CITRIC ACID MONOHYDRATE   GLYCERYL MONOSTEARATE   MALTODEXTRIN   MEDIUM-CHAIN TRIGLYCERIDES   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   SUCROSE

Product Characteristics Color RED Score no score Shape SQUARE Size 13mm Flavor CHERRY Imprint Code BP;814 Contains

Packaging # NDC Package Description Multilevel Packaging 1 64376-814-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/28/2011

Labeler - Boca Pharmacal, Inc (170266089)

Registrant - Boca Pharmacal, Inc (170266089)

Establishment
Name	Address	ID/FEI	Operations
Cispharma, Inc		833171445	MANUFACTURE

Revised: 01/2012Boca Pharmacal, Inc

Multivitamins with Folic Acid/Iron

Pronunciation: muhl-tee-VYE-ta-mins/FOE-lik AS-id/EYE-urn
Generic Name: Multivitamins with Folic Acid/Iron
Brand Name: Examples include Ferocon and TL Icon

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call a doctor or poison control center right away.

Multivitamins with Folic Acid/Iron is used for:

Treating or preventing low levels of vitamins, folic acid, and iron in the body. It may also be used for other conditions as determined by your doctor.

Multivitamins with Folic Acid/Iron is a vitamin, folic acid, and iron supplement. It works by providing extra vitamins, folic acid, and iron to the body when you need more than what you get in your diet.

Do NOT use Multivitamins with Folic Acid/Iron if:

• you are allergic to any ingredient in Multivitamins with Folic Acid/Iron


• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Multivitamins with Folic Acid/Iron:

Some medical conditions may interact with Multivitamins with Folic Acid/Iron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), certain blood disorders (eg, hemolytic or pernicious anemia, porphyria cutanea tarda, thalassemia), glucose-6-phosphate-dehydrogenase (G6PD) deficiency, or a peptic ulcer


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Multivitamins with Folic Acid/Iron. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by Multivitamins with Folic Acid/Iron


• Cephalosporin antibiotics (eg, cephalexin), eltrombopag, hydantoins (eg, phenytoin), methyldopa, mycophenolate, penicillamine, quinolone antibiotics (eg, ciprofloxacin), tetracycline antibiotics (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Multivitamins with Folic Acid/Iron

This may not be a complete list of all interactions that may occur. Ask your health care provider if Multivitamins with Folic Acid/Iron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Multivitamins with Folic Acid/Iron:

Use Multivitamins with Folic Acid/Iron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Multivitamins with Folic Acid/Iron by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Multivitamins with Folic Acid/Iron with a full glass of water (8 oz/240 mL).


• Do not take an antacid within 1 hour before or 2 hours after you take Multivitamins with Folic Acid/Iron.


• Avoid taking Multivitamins with Folic Acid/Iron with dairy products; they may interfere with the absorption of the iron in Multivitamins with Folic Acid/Iron.


• If you miss a dose of Multivitamins with Folic Acid/Iron, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Multivitamins with Folic Acid/Iron.

Important safety information:

• Do not take large doses of vitamins while you use Multivitamins with Folic Acid/Iron unless your doctor tells you to.


• Multivitamins with Folic Acid/Iron may discolor the stools. This is normal and not a cause for concern.


• Multivitamins with Folic Acid/Iron has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Multivitamins with Folic Acid/Iron has folic acid and iron in it. Before you start any new medicine, check the label to see if it has folic acid or iron in it too. If it does not or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Multivitamins with Folic Acid/Iron while you are pregnant. It is not known if Multivitamins with Folic Acid/Iron is found in breast milk. If you are or will be breast-feeding while you use Multivitamins with Folic Acid/Iron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Multivitamins with Folic Acid/Iron:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit; persistent nausea, vomiting, or diarrhea; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; blood in the vomit; diarrhea; headache; nausea; vomiting.

Proper storage of Multivitamins with Folic Acid/Iron:

Store Multivitamins with Folic Acid/Iron at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Multivitamins with Folic Acid/Iron out of the reach of children and away from pets.

General information:

• If you have any questions about Multivitamins with Folic Acid/Iron, please talk with your doctor, pharmacist, or other health care provider.


• Multivitamins with Folic Acid/Iron is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Multivitamins with Folic Acid/Iron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Multivitamins with Folic Acid/Iron resources

• Multivitamins with Folic Acid/Iron Use in Pregnancy & Breastfeeding
• Drug Images
• Multivitamins with Folic Acid/Iron Drug Interactions
• Multivitamins with Folic Acid/Iron Support Group
• 11 Reviews for Multivitamins with Folic Acid/Iron - Add your own review/rating

Compare Multivitamins with Folic Acid/Iron with other medications

• Anemia
• Vitamin/Mineral Supplementation and Deficiency

Multivitamins with Minerals

Pronunciation: MUL-ti-VYE-ta-mins/MIN-er-als
Generic Name: Multivitamins with Minerals
Brand Name: Examples include Protegra and Vicon Forte

Multivitamins with Minerals is used for:

Treating or preventing low levels of vitamins and minerals in the body. It may also be used for other conditions as determined by your doctor.

Multivitamins with Minerals is a vitamin and mineral supplement. It works by providing extra vitamins and minerals to the body.

Do NOT use Multivitamins with Minerals if:

• you are allergic to any ingredient in Multivitamins with Minerals

Contact your doctor or health care provider right away if any of these apply to you.

Before using Multivitamins with Minerals:

Some medical conditions may interact with Multivitamins with Minerals. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Multivitamins with Minerals.

Ask your health care provider if Multivitamins with Minerals may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Multivitamins with Minerals:

Use Multivitamins with Minerals as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Multivitamins with Minerals by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Multivitamins with Minerals, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Multivitamins with Minerals.

Important safety information:

• Do not take large doses of vitamins while you use Multivitamins with Minerals unless your doctor tells you to.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Multivitamins with Minerals while you are pregnant. It is not known if Multivitamins with Minerals is found in breast milk. If you are or will be breast-feeding while you use Multivitamins with Minerals, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Multivitamins with Minerals:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Multivitamins with Minerals. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vomiting.

Proper storage of Multivitamins with Minerals:

Store Multivitamins with Minerals at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Multivitamins with Minerals out of the reach of children and away from pets.

General information:

• If you have any questions about Multivitamins with Minerals, please talk with your doctor, pharmacist, or other health care provider.


• Multivitamins with Minerals is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Multivitamins with Minerals. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Multivitamins with Minerals resources

• Multivitamins with Minerals Use in Pregnancy & Breastfeeding
• Multivitamins with Minerals Drug Interactions
• Multivitamins with Minerals Support Group
• 4 Reviews for Multivitamins with Minerals - Add your own review/rating

Compare Multivitamins with Minerals with other medications

• Vitamin/Mineral Supplementation and Deficiency

Mucinex Maximum Strength

Generic Name: guaifenesin

Dosage Form: tablet, extended release
MAXIMUM STRENGTH

Mucinex ®

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 1200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

• for children under 12 years of age

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema


• cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not crush, chew, or break tablet


• take with a full glass of water


• this product can be administered without regard for the timing of meals


• adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.


• children under 12 years of age: do not use

Other information

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing


• store between 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser Inc.

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Carton

MAXIMUM STRENGTH

NDC 63824-023-36

Mucinex®

1200 mg guaifenesin extended-release bi-layer tablets

EXPECTORANT

12

HOUR

✔

Thins And Loosens Mucus

✔

Relieves Chest Congestion

28 EXTENDED-RELEASE BI-LAYER TABLETS

MUCINEX  MAXIMUM STRENGTH guaifenesin  tablet, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-023 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 1200 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (blue and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63824-023-14 1 BOTTLE In 1 CARTON contains a BOTTLE 1 14 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-023-14) 2 63824-023-36 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-023-36) 3 63824-023-28 1 BOTTLE In 1 CARTON contains a BOTTLE 3 28 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-023-28) 4 63824-023-43 1 BOTTLE In 1 BLISTER PACK contains a BOTTLE 4 42 TABLET In 1 BOTTLE This package is contained within the BLISTER PACK (63824-023-43) 5 63824-023-45 1 BOTTLE In 1 BLISTER PACK contains a BOTTLE 5 44 TABLET In 1 BOTTLE This package is contained within the BLISTER PACK (63824-023-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021282	08/11/2009

Labeler - Reckitt Benckiser, Inc. (094405024)

Revised: 12/2009Reckitt Benckiser, Inc.

More Mucinex Maximum Strength resources

• Mucinex Maximum Strength Side Effects (in more detail)
• Mucinex Maximum Strength Use in Pregnancy & Breastfeeding
• Drug Images
• Mucinex Maximum Strength Support Group
• 51 Reviews for Mucinex Maximum Strength - Add your own review/rating

Compare Mucinex Maximum Strength with other medications

• Bronchitis
• Cough
• Fibromyalgia

Mucinex DM Maximum Strength

guaifenesin and dextromethorphan hydrobromide

Dosage Form: tablet, extended release
Mucinex®DM

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)	Purpose
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


• temporarily relieves:
  
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  
  
  • the intensity of coughing
  
  
  • the impulse to cough to help you get to sleep
  
  

Warnings

Do not use

• for children under 12 years of age


• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema


• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not crush, chew, or break tablet


• take with a full glass of water


• this product can be administered without regard for timing of meals


• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours


• children under 12 years of age: do not use

Other information

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing


• store at 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:

Reckitt Benckiser Inc.

Parsippany, NJ 07054-0224

©RBI 2009

PRINCIPAL DISPLAY PANEL - 1200 mg Carton

MAXIMUM STRENGTH

NDC 63824-072-35

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-

SAME RELIEF

Thins And Loosens Mucus

Controls Cough

14 EXTENDED-RELEASE BI-LAYER TABLETS

MUCINEX DM  MAXIMUM STRENGTH guaifenesin and dextromethorphan hydrobromide  tablet, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-072 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 1200 mg Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 60 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63824-072-35 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-35) 2 63824-072-36 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-36) 3 63824-072-39 1 BOTTLE In 1 CARTON contains a BOTTLE 3 38 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-39) 4 63824-072-45 1 BOTTLE In 1 CARTON contains a BOTTLE 4 44 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021620	03/31/2009

Labeler - Reckitt Benckiser, Inc. (094405024)

Revised: 12/2009Reckitt Benckiser, Inc.

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• Mucinex DM Maximum Strength Side Effects (in more detail)
• Mucinex DM Maximum Strength Dosage
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• Mucinex DM Maximum Strength Support Group
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• Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)


• Robitussin DM infant drops


• Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

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• Cough
• Expectoration

mumps virus vaccine

Generic Name: mumps virus vaccine (MUMPS VYE rus)

Brand Names: Mumpsvax

What is mumps virus vaccine?

Mumps is a serious diseases caused by a virus. It is spread from person to person through the air.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

The mumps vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, and rubella vaccine is for use in children who are at least 12 months old.

Like any vaccine, the mumps vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The mumps vaccine is usually given as one shot, followed later by a booster vaccine with measles, mumps, and rubella (MMR) vaccine. The first mumps vaccine is usually given when the child is 12 to 15 months old. The MMR shots are then given before the child starts elementary school. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with mumps is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing mumps virus, or if you are allergic to:

• 
  

  gelatin; or

  
  


• 
  

  neomycin (Mycifradin, Neo-Fradin, Neo-Tab).

  
  

You should also not receive this vaccine if you have:

• 
  

  severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;

  
  


• 
  

  a cancer such as leukemia or lymphoma; or

  
  


• 
  

  if you are pregnant.

  
  

Before receiving this vaccine, tell the doctor if you have:

• 
  

  thrombocytopenia purpura (easy bruising or bleeding);

  
  


• 
  

  active tuberculosis infection;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if you have received an immune globulin or other blood product within the past year.

  
  

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a mumps vaccine if you are pregnant. Wait until after your child is born to receive the vaccine.

A woman should avoid becoming pregnant for at least 3 months after receiving a mumps vaccine.

A woman should not receive this vaccine without telling the doctor if she is breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection (shot) under the skin. Your child will receive this injection in a doctor's office or other clinic setting.

The mumps vaccine is usually given as one shot, followed later by a booster vaccine with measles, mumps, and rubella (MMR) vaccine. The first mumps vaccine is usually given when the child is 12 to 15 months old. The MMR shots are then given before the child starts elementary school. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who treats you if you have received a mumps vaccine within the past 4 to 6 weeks.

What happens if I miss a dose?

Since this vaccine is usually given as only one dose, your child may not be on a booster schedule. If the child is on a booster schedule, contact your doctor if you will miss a dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Your child should not receive a "live" vaccine such as measles, mumps, rubella (MMR), oral polio, yellow fever, or varicella (chickenpox) for at least 4 weeks after receiving mumps vaccine. The other live vaccine may not work as well during this time, and may not fully protect your child from disease.

This vaccine side effects

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with mumps is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

• 
  

  problems with hearing or vision;

  
  


• 
  

  extreme drowsiness, fainting;

  
  


• 
  

  fussiness, irritability, crying for an hour or longer;

  
  


• 
  

  easy bruising or bleeding, weakness;

  
  


• 
  

  seizure (black-out or convulsions);

  
  


• 
  

  high fever (within a few hours or a few days after the vaccine); or

  
  


• 
  

  swelling of the testicles (scrotum) in a male child.

  
  

Less serious side effects include:

• 
  

  burning or stinging where the shot was given;

  
  


• 
  

  low fever;

  
  


• 
  

  mild fussiness or crying;

  
  


• 
  

  cough, runny nose; or

  
  


• 
  

  diarrhea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Mumps virus vaccine Dosing Information

Usual Adult Dose for Mumps Prophylaxis:

0.5 mL subcutaneously in the outer aspect of the upper arm.

Usual Pediatric Dose for Mumps Prophylaxis:

>= 1 year: 0.5 mL subcutaneously in the outer aspect of the upper arm. Primary vaccination is recommended at age 12 to 15 months.

Revaccination with measles/mumps/rubella vaccine is recommended before entry into elementary school.

What other drugs will affect mumps vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

More mumps virus vaccine resources

• Mumps virus vaccine Side Effects (in more detail)
• Mumps virus vaccine Use in Pregnancy & Breastfeeding
• Mumps virus vaccine Drug Interactions
• Mumps virus vaccine Support Group
• 0 Reviews for Mumps virus vaccine - Add your own review/rating

• Mumps Virus Vaccine MedFacts Consumer Leaflet (Wolters Kluwer)


• Mumpsvax Advanced Consumer (Micromedex) - Includes Dosage Information

Compare mumps virus vaccine with other medications

• Mumps Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: mumps virus vaccine side effects (in more detail)

Murine Ear Drops otic

Generic Name: carbamide peroxide (otic) (KAR ba mide per OX ide OH tik)

Brand Names: Auraphene-B, Auro Ear Drops, Debrox, Ear Wax, Ear Wax Removal, Mollifene, Murine Ear Drops

What is carbamide peroxide?

Carbamide peroxide otic (for the ears) is used to soften and loosen ear wax, making it easier to remove.

Carbamide peroxide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about carbamide peroxide?

You should not use this medication if you are allergic to carbamide peroxide, or if you have a ruptured ear drum. Do not use carbamide peroxide if you have any signs of ear infection or injury, such as pain or other irritation, or drainage, discharge, or bleeding from the ear. Do not use this medication in a child younger than 12 years old without the advice of a doctor.

You may hear a bubbling sound inside your ear after using carbamide peroxide ear drops. This is caused by the foaming action of carbamide peroxide, which helps break up the wax inside your ear.

Do not use carbamide peroxide for longer than 4 days in a row. Call your doctor if your ear symptoms do not improve after treatment, or if they get worse. Stop using carbamide peroxide and call your doctor at once if you have a serious side effect such as dizziness, ear pain or other irritation, decreased hearing for a prolonged period of time, or discharge or bleeding from the ear.

What should I discuss with my health care provider before using carbamide peroxide?

You should not use this medication if you are allergic to carbamide peroxide, or if you have any signs of ear infection or injury such as:

• 
  

  ear pain, itching, or other irritation;

  
  


• 
  

  drainage or discharge from the ear; or

  
  


• 
  

  bleeding from the ear.

  
  

FDA pregnancy category C. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Do not use this medication in a child younger than 12 years old without the advice of a doctor.

How should I use carbamide peroxide?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of this medication for children is 1 to 5 drops per ear twice daily. The usual dose for adults is 5 to 10 drops per ear twice daily. Follow your doctor's instructions. Carbamide peroxide may be used for up to 4 days, unless your doctor has told you otherwise.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and drop the correct number of ear drops into the ear.

You may hear a bubbling sound inside your ear after putting in the drops. This is caused by the foaming action of carbamide peroxide, which helps break up the wax inside your ear.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton ball to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

Wipe the tip of the medicine bottle with a clean tissue. Do not wash the dropper tip.

Carbamide peroxide may be packaged with a bulb syringe that is used to flush out your ear with water.

When filling the bulb syringe, use only warm water that is body temperature (no warmer than 98 degrees F). Do not use hot or cold water.

Hold your head sideways with your ear over a sink or bowl.

Gently pull your ear lobe back and downward to open up the ear canal. Place the tip of the bulb syringe at the opening of your ear canal. Do not insert the tip into your ear.

Squeeze the bulb syringe gently to release the water into your ear. Do not squirt the water with any force into your ear, or you could damage your ear drum.

Remove the syringe and allow the water to drain from your ear into the sink or bowl.

Do not use carbamide peroxide for longer than 4 days in a row. Call your doctor if your ear symptoms do not improve after treatment, or if they get worse.

Clean the bulb syringe by filling it with plain water and emptying it several times. Do not use soap or other cleaning chemicals. Allow the syringe to air dry.

Store the medication and the bulb syringe at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

Since carbamide peroxide is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of carbamide peroxide is not likely to cause life-threatening symptoms.

What should I avoid while using carbamide peroxide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Carbamide peroxide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using carbamide peroxide and call your doctor at once if you have a serious side effect such as:

• 
  

  dizziness;

  
  


• 
  

  ear pain, itching, or other irritation;

  
  


• 
  

  discharge or bleeding from the ear; or

  
  


• 
  

  decreased hearing for a prolonged period of time.

  
  

Less serious side effects may include:

• 
  

  temporary decrease in hearing after using the ear drops;

  
  


• 
  

  mild feeling of fullness in the ear; or

  
  


• 
  

  mild itching inside the ear.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect carbamide peroxide?

It is not likely that other drugs you take orally or inject will have an effect on carbamide peroxided otic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Murine Ear Drops resources

• Murine Ear Drops Side Effects (in more detail)
• Murine Ear Drops Use in Pregnancy & Breastfeeding
• Murine Ear Drops Support Group
• 0 Reviews for Murine Ear - Add your own review/rating

Compare Murine Ear Drops with other medications

• Ear Wax Impaction

Where can I get more information?

• Your pharmacist can provide more information about carbamide peroxide.

See also: Murine Ear side effects (in more detail)

Mucinex Junior Strength Granules

Pronunciation: gwye-FEN-eh-sin
Generic Name: Guaifenesin
Brand Name: Examples include Mucinex Children's and Mucinex Junior Strength

Mucinex Junior Strength Granules are used for:

Relieving symptoms of cough and mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Mucinex Junior Strength Granules are an expectorant. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.

Do NOT use Mucinex Junior Strength Granules if:

• you are allergic to any ingredient in Mucinex Junior Strength Granules

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mucinex Junior Strength Granules:

Some medical conditions may interact with Mucinex Junior Strength Granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a persistent cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus


• if you have phenylketonuria

Some MEDICINES MAY INTERACT with Mucinex Junior Strength Granules. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Mucinex Junior Strength Granules are known at this time.

Ask your health care provider if Mucinex Junior Strength Granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mucinex Junior Strength Granules:

Use Mucinex Junior Strength Granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mucinex Junior Strength Granules by mouth with or without food.


• Drinking extra fluids while you are taking Mucinex Junior Strength Granules are recommended. Check with your doctor for instructions.


• Empty the entire contents of the packet onto the tongue and swallow. For best taste, do not chew before swallowing.


• If you miss a dose of Mucinex Junior Strength Granules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mucinex Junior Strength Granules.

Important safety information:

• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Different brands of Mucinex Junior Strength Granules may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mucinex Junior Strength Granules while you are pregnant. It is not known if Mucinex Junior Strength Granules are found in breast milk. If you are or will be breast-feeding while you use Mucinex Junior Strength Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mucinex Junior Strength Granules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mucinex Junior Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Mucinex Junior Strength Granules:

Store Mucinex Junior Strength Granules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mucinex Junior Strength Granules out of the reach of children and away from pets.

General information:

• If you have any questions about Mucinex Junior Strength Granules, please talk with your doctor, pharmacist, or other health care provider.


• Mucinex Junior Strength Granules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mucinex Junior Strength Granules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mucinex Junior Strength resources

• Mucinex Junior Strength Side Effects (in more detail)
• Mucinex Junior Strength Use in Pregnancy & Breastfeeding
• Mucinex Junior Strength Support Group
• 0 Reviews for Mucinex Junior Strength - Add your own review/rating

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