Drug Facts
Active Ingredients Purpose
(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg ................... Antitussive
Guaifenesin USP 100 mg ........................... Expectorant
The following Structured Product Label (SPL) was submitted to the FDA by Leading Pharma, Llc for the product Codeine Guaifenesin (NDC 69315-248). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, uses, warnings, ask your doctor before use if, when using this product, stop use and ask a doctor if, directions, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg ................... Antitussive
Guaifenesin USP 100 mg ........................... Expectorant
Adults and children 12 years of age and over: | 2 tsp (10 mL) every 4 hours, or as directed by a doctor. |
Children 6 to under 12 years of age: | 1 tsp (5 mL) every 4 hours, or as directed by a doctor. |
Children under 6 years of age: | Consult a doctor. |
Other Information
Store at controlled room temperature 15°-30°C (59°-86°F).
Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol
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