Active Ingredient
(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg
(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Codeine-guaifenesin (NDC 17856-0500). 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 active ingredient, purpose, uses, ask your doctor before use if, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg
(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg
Antitussive
Expectorant
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| 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. |
Store at controlled room temperature 15°-30°C (59°-86°F).
Cherry Flavor, Citric Acid, Glycerin, Polyethylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
NDC 17856-0500-5
Codeine-Guaifenesin Oral Solution
10-100 mg/5 mL
Antitussive
Expectorant
16 fl. oz. (473 mL)
* Please review the disclaimer below.