国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Dispensing Solutions, Inc.
GUAIFENESIN
GUAIFENESIN 100 mg in 5 mL
ORAL
OTC DRUG
Expectorant / Cough Suppressant 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. Hypersensitivity to any of the ingredients.
Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms: NDC 682588-8904-04 (4 fl oz bottle)
OTC monograph final
GUAIFENESIN AND CODEINE PHOSPHATE- GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION DISPENSING SOLUTIONS, INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- GUAIFENSIN AND CODEINE PHOSPHATE ORAL SOLUTION USP CV ACTIVE INGREDIENT Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg. Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ. INACTIVE INGREDIENT _Inactive Ingredients:_ Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol. _Sodium Content:_ 5 mg/5 mL PURPOSE _Expectorant / Cough Suppressant_ ACTIONS This product 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. 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. CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 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 physician. 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 directe 完全なドキュメントを読む