Prescription Drugs

CLINICAL PHARMACOLOGY This syrup preparation combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough. As a result, dry, unproductive coughs become more productive and less frequent.

DESCRIPTION Guaifenesin and Codeine Each 5 ml (1 teaspoonful) contains: Guaifenesin, USP: 100 mg Codeine Phosphate, USP: 10 mg (Warning: May be habit forming) Alcohol 3.5 percent In a palatable, aromatic syrup. Inactive ingredients: (guaifenesin and codeine) Caramel, Citric Acid, FD&C Red 40, Flavors, Glycerin, Saccharin Sodium, Sodium Benzoate, Sorbitol, Water.

INDICATIONS Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. DOSAGE AND ADMINISTRATION No information provided. HOW SUPPLIED No information provided.

PATIENT INFORMATION See WARNINGS.

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

SIDE EFFECTS No information provided. DRUG INTERACTIONS Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone. Directions Take orally as stated below or use as directed by a doctor. Adults and children 12 years of age and over: 2 teaspoonfuls every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; children 6 to under 12 years: 1 teaspoonful every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period; children under 6 years: consult a doctor. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.

WARNINGS A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). PRECAUTIONS No information provided.