BIDEX-400- guaifenesin tablet
SJ Pharmaceuticals
Disclaimer: 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.
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Drug Facts
Active ingredient
(in each immediate release tablet)
Guaifenesin 400 mg
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
- 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.
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
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.
|
Take with a full glass of water
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
Distributed by:
SJ Pharmaceuticals
4200 North Parkway NW, Bldg. 12
Atlanta, GA 30327
Rev. 10/12
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel for 100 tablets label:
NDC 24839-777-01
BIDEX
®-400 TABLETS
Each immediate release tablet contains:
Guaifenesin.......................400 mg
Expectorant
CONTENTS: 100 Tablets
SJP
SJ PHARMACEUTICALS