Active Ingredient (In Each Caplet)
Guaifenesin 400 mg
Guaifenesin Tablet
FDA Label NDC 71335-9616
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Guaifenesin (NDC 71335-9616). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (Lbl713359616)
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