Rx Only

Guiadrine G-1200mg Tablets (guaifenesin)*

NDC# 51991-0024-01 (100s)

Description:  Each long-acting, dye-free tablet contains:  Guaifenesin 1200mg.

Inactive Ingredients:  Maltodextrin, methocel, magnesium stearate, povidone.

Chemically, guaifenesin is 3-(2-methoxyphenoxy)-1,2-propanediol and has the following structural formula:

C10H14O4

MW = 198.22

Clinical Pharmacology:  Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions.  By reducing the viscosity of secretions, guaifenesin increases the efficiency of the mucocilliary mechanism in removing accumulated secretions from the upper and lower airway.  Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine.  Guaifenesin has a plasma half-life of one hour.  The major urinary metabolite is -(2-methoxyphenoxy) lactic acid.

Indications and usage:  Guaifenesin LA Tablets are indicated for the temporary relief of coughs associated with upper respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion.  The drug is effective in productive as well as non-productive cough, but is of particular value in dry, non-productive cough which tends to injure the mucous membrane of the air passages.

Contraindications:  Guaifenesin LA Tablets are contraindicated in patients with hypersensitivity to guaifenesin.

Precautions:  Before prescribing medication to suppress or modify cough, it is important that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Drug Interactions:  None known.

Drug/Laboratory Test Interactions:  Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels.  Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome.  It may also elevate the VMA test for catechols.  Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility:  No data are available on the long-term potential of guaifenesin for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

Pregnancy:  Category C:  Animal reproduction studies have not been conducted with Guaifenesin LA Tablets.  It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Guaifenesin LA Tablets should be given to a pregnant woman only if clearly needed.

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 this product is 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.

Adverse Reactions:  No serious side effects from guaifenesin has been reported.

Overdosage: Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is low.  Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity.  In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug.  Gastric emptying (syrup of ipecac) and/or lavage is recommended as soon as possible after ingestion.

Dosage and Administration:

Adults and children over 12 years of age:  One tablet every 12 hours not to exceed 2 tablets (2400mg) in 24 hours.

Children 6 to 12 years:  One-half tablet every 12 hours not to exceed 1 tablet (1200mg) in 24 hours.

 

Tablets may be broken in half (but not crushed or chewed) without affecting the release of the medication.

How Supplied:

Guaifenesin SR Tablets:  Bottles of 100 tablets.  White tablets are debossed with "B 024" on one side.

Store at controlled room temperature between 15oC and 30oC (59oF and 86oF).

Dispense in tight containers.

KEEP OUT OF REACH OF CHILDREN

MANUFACTURED BY:

Intermax Pharmaceuticals, Inc.

Farmingdale, NY  11735  USA

DISTRIBUTED BY:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL  33429  USA

* This information has been adapted from the package insert for this product.

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