DESCRIPTION

Guaifenesin NR syrup is an expectorant available in liquid form for oral administration.Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg.

INACTIVE INGREDIENTS: Caramel, Citric Acid, Flavor, Glycerin, Propylene Glycol, Saccharin Sodium, Sodium Benzoate, Sorbitol Solution, Water. It may contain Sodium Citrate.

Structure

Guaifenesin (glyceryl guaiacolate) has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C10H14O4, with a molecular weight of 198.21. It is a white, colorless crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; freely soluble in ethanol. Guaifenesin is readily absorbed from the gastro-intestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic 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

This product is contraindicated in patients hypersensitive to any of the ingredients.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy
Teratogenic Effects-Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients, unless in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers: It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanilylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

ADVERSE REACTIONS

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache and rash (including urticaria) have been reported rarely.

OVERDOSAGE

The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

In massive over dosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and older: Two to four teaspoonfuls (200 mg to 400 mg) every four hours, not to exceed 2400 mg (24 teaspoonfuls) in 24 hours.

Children 6 years to under 12 years of age: One to two teaspoonfuls (100 mg to 200 mg) every four hours, not to exceed 1200 mg (12 teaspoonfuls) in 24 hours.

Children 2 to under 6 years of age: 1/2 to 1 teaspoonful (50 mg to 100 mg) every four hours, not to exceed 600 mg (6 teaspoonfuls) in 24 hours.

Children 6 months to under 2 years of age: A common dosage is 1/4 to 1/2 teaspoonful (25 mg to 50 mg) every 4 hours, not to exceed 300 mg (3 teaspoonfuls) in 24 hours. Individualized dosage should be determined by evaluation of patient.

HOW SUPPLIED

Guaifenesin NR Liquid is available in one pint (473 mL), and one gallon (3785 mL).

Store at controlled room temperature 15°-30°C (59°-86°F).
PROTECT FROM LIGHT. KEEP BOTTLE TIGHTLY CLOSED.
Dispense in a tight container as defined in the USP.

Manufactured by:
Silarx Pharmaceuticals, Inc.
Spring Valley, NY 10977

Container Label

GUAIFENESIN NR
guaifenesin liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	54838-123
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
glycerin
propylene glycol
saccharin sodium
sodium benzoate
sorbitol
sodium citrate

Product Characteristics
Color	brown (Caramel)	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54838-123-80	473 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2000

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 12/2010Silarx Pharmaceuticals, Inc