|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug FactsActive ingredient
(in each immediate release tablet)
Guaifenesin 400 mg
UsesHelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
Stop use and ask doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
|Adults and children 12 years|
of age and over:
|1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours.
|Children under 12 years of age:||consult a doctor.
- Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing
- Store between 20°-25°C (68°-77°F).
- Supplied in a tight, light-resistant container with a child-resistant cap.
- Bidex-400 Tablets are white to off white, biconex, capsule shaped tablets, debossed "649" bisect "649" on one side and plain on the other side.
Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid. May also contain sodium starch glycolate.
Questions or comments?1 (877) 604-7575
4200 North Parkway NW, Bldg. 12
Atlanta, GA 30327
|Labeler - SJ Pharmaceuticals (845662720)|
|Registrant - Pernix Manufacturing, LLC (078641814)|
|Pernix Manufacturing, LLC dba Great Southern Laboratories||078641814||manufacture(24839-777)|
Document Id: 0c51a0bb-4771-40ba-916d-e8c6d8596083
Set id: 41e795d8-755a-41d0-b1ce-804334559e09
Effective Time: 20121109