GUAIFENESIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

Contract Pharmacy Services-PA

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis. Hypersensitivity to any of the ingredients.

Product summary:

Guaifenesin Tablets — Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP—available in blisters of 30 (NDC 67046-250-30) STORAGE — Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Qualitest PHARMACEUTICALS® Huntsville, AL 35811 8180142 Rev 5/08

Authorization status:

unapproved drug other

Summary of Product characteristics

GUAIFENESIN- GUAIFENESIN TABLET
CONTRACT PHARMACY SERVICES-PA
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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PROFESSIONAL LABELING INFORMATION AND DIRECTIONS FOR USE
THESE PRODUCTS LABELED FOR SALE ON PRESCRIPTION ONLY.
GUAIFENESIN TABLETS
DESCRIPTION
Guaifenesin (glyceryl guaiacolate) has the chemical name
3-(2-methoxyphenoxy)-1,2-propanediol. Its
molecular formula is C
H O with a molecular weight of 198.21. It is a white or slightly gray
crystalline substance with a slightly bitter aromatic taste. One gram
dissolves in 20 mL water at 25°C; it
is freely soluble in ethanol. Guaifenesin is readily absorbed from the
GI tract and is rapidly metabolized
and excreted in the urine. Guaifenesin has a plasma half-life of one
hour. The major urinary metabolite
is β-(2-methoxyphenoxy) lactic acid.
Guaifenesin is an expectorant available for oral administration as:
TABLETS — each containing 200 mg guaifenesin, USP.
_Other ingredients:_ crospovidone, D&C red #30 aluminum lake,
magnesium stearate, microcrystalline
cellulose, polysaccharides, pregelatinized starch, silicon dioxide,
sodium starch glycolate, and stearic
acid.
CLINICAL PHARMACOLOGY
Guaifenesin is an expectorant, the action of which promotes or
facilitates the removal of secretions
from the respiratory tract. By increasing sputum volume and making
sputum less viscous, guaifenesin
facilitates expectoration of retained secretions.
INDICATIONS AND USAGE
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passageways of
bothersome mucus, drain bronchial tubes and make coughs more
productive. Helps loosen phlegm and
thin bronchial secretions in patients with stable chronic bronchitis.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
PRECAUTIONS
_Carcinogenesis, Mutagenesis, Impairment of Fertility:_ Animal studies
to assess the long-term
carcinogenic and mutagenic potential or t