Drug Catalog - Product Detail
FLUTABS TB 200/60/20/500 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51991-0442-01 | BRECKENRIDGE | NA | NA | NA |
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Description
Description Each tablet contains: Guaifenesin 200 mg Pseudoephedrine HCl 60 mg Dextromethorphan HBr 20 mg Acetaminophen 500 mg Flutabs™ also contain the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, starch and stearic acid. Flutabs™ contain ingredients in the following therapeutic classes: expectorant, nasal decongestant, antitussive, pain reliever. Guaifenesin is an expectorant having the chemical name, 1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-. With the following structural formula: C 10 H 14 O 4 M.W. 198.22 Pseudoephedrine hydrochloride is a nasal decongestant having the chemical name: Benzenemethanol, α-[1-(methylamino)ethyl]-, [ S -( R*,R* )]-, hydrochloride. With the following structural formula: C 10 H 15 NO • HCl M.W. 201.69 Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic, and is antitussive having the chemical name: Morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate. With the following structural formula: C 18 H 25 NO • HBr • H 2 O M.W. 370.32 Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic having the chemical name, 4'hydroxyacetanilide. With the following structural formula: C 8 H 9 NO 2 M.W. 151.16 Chemical Structure Chemical Structure Chemical Structure Chemical Structure
How Supplied
HOW SUPPLIED Flutabs™ are available as a white, dye-free, caplet-shaped tablet, debossed B-442 on one side, scored on the other. Bottles of 100s (NDC: 51991-442-01). KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F). See USP Controlled Room Temperature. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Indications & Usage
INDICATIONS AND USAGE For the temporary relief of minor aches and pains, headache, muscular aches and sore throat associated with cold or flu, and to reduce fever. Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive. Flutabs™ is also indicated for the relief of nasal congestion due to the common cold, hay fever, or other respiratory allergies and nasal congestion associated with sinusitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and older: One tablet four times per day not to exceed 4 tablets in 24 hours. (see PRECAUTIONS, Pediatric Use . ) Geriatric patients may be more sensitive to the effects of this medication. Adjust adult dose accordingly.