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 Bryant Ranch Prepack. 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.
Active Ingredient (In Each Caplet)
Guaifenesin 400 mg
Purpose
Expectorant
Uses
helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone 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 then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 take more than 6 doses in any 24- hour period
- this product is not intended for use in children under 12 years of age
- adults & children 12 years and over: 1 caplet every 4 hours
- children under 12 years: do not use
Other Information
store at 15°-30°C (59°-86°F)
Inactive Ingredients
colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid
Questions Or Comments?
call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday
Other
Drug Facts continued on back of label
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Reliable-1 Laboratoreis LLC
Valley Stream, Ny 11580 www.reliable1labs.com
How Supplied
NDC: 71335-9616-1: 30 Tablets in a BOTTLE
NDC: 71335-9616-2: 20 Tablets in a BOTTLE
NDC: 71335-9616-3: 50 Tablets in a BOTTLE
NDC: 71335-9616-4: 60 Tablets in a BOTTLE
NDC: 71335-9616-5: 40 Tablets in a BOTTLE
Package Label.Principal Display Panel
Guaifenesin 400mg Tablet
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