Label: BIDEX-400 - guaifenesin tablet
- NDC Code(s): 24839-777-01
- Packager: SJ Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts
(in each immediate release tablet)
Guaifenesin 400 mg
Helps 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
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.
- 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)
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.Close
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.
- Other information
- 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 ingredients
colloidal 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
- Product Packaging
The packaging below represents the labeling currently used.
Principal display panel for 100 tablets label:
Each immediate release tablet contains:
CONTENTS: 100 Tablets
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24839-777 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg Inactive Ingredients Ingredient Name Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) Croscarmellose Sodium (UNII: M28OL1HH48) Hypromelloses (UNII: 3NXW29V3WO) Maltodextrin (UNII: 7CVR7L4A2D) Povidones (UNII: FZ989GH94E) Cellulose, Microcrystalline (UNII: OP1R32D61U) Stearic Acid (UNII: 4ELV7Z65AP) Product Characteristics Color white (white to off white) Score 2 pieces Shape CAPSULE Size 15mm Flavor Imprint Code 649;649 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24839-777-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/09/2012 Labeler - SJ Pharmaceuticals (845662720) Registrant - Pernix Manufacturing, LLC (078641814) Establishment Name Address ID/FEI Business Operations Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(24839-777)