FDA Label for Guaifenesin
View Indications, Usage & Precautions
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Contract Pharmacy Services-pa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Patient Medication Information
Major 44-588 Major Pharmaceuticals LNK International, Inc. LNK International, Inc. LNK International, Inc. LNK International, Inc. Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID FD&C RED NO. 40 SILICON DIOXIDE dark 44;588 Active ingredient (in each immediate-release tablet) Guaifenesin 200 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 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 exceed 6 doses in 24 hours take with a full glass of water adults and children 12 yearsof age and over 1 to 2 tablets every4 hours children 6 to under 12 yearsof age ½ to 1 tablet every4 hours children under 6 years of age consult a physician Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package Inactive ingredients FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid Questions or comments? (800) 616-2471 Principal Display Panel NDC 0904-5154-60 MAJOR® GUAIFENESIN TABLETSGuaifenesin 200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 100 Tablets Immediate Release 50844 REV0812B58812Distributed by MAJOR® PHARMACEUTICALS 31778 Enterprise Drive, Livonia, MI 48150 USARe-Order No. 238163 M-17 Rev. 04/13 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Major 44-588 Major 44-588 REPACKAGED BY: COUPLER ENTERPRISES INC. NDJA 4/19/18
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 yearsof age and over 1 to 2 tablets every4 hours children 6 to under 12 yearsof age ½ to 1 tablet every4 hours children under 6 years of age consult a physician
Warnings
Warnings 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
Inactive Ingredient
Inactive ingredients FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid
Otc - Active Ingredient
Guaifenesin 200 mg
Otc - Purpose
Expectorant
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