Active Ingredients (In Each Teaspoonful (5 Ml))
Codeine phosphate USP 10 mg
Guaifenesin USP 100 mg
Codeine Phosphate And Guaifenesin
FDA Label NDC 17856-0208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Codeine Phosphate And Guaifenesin (NDC 17856-0208). 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 ingredients (in each teaspoonful (5 ml)), purpose, uses, keep out of reach of children., directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antitussive (Cough Suppressant)
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- relieves your cough to help you sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves cough associated with the common cold
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed 6 doses in 24 hours
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 20° to 25°C (68° to 77°F)
Inactive Ingredients
Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose
Principal Display Panel
NDC 17856-0208-1
CODEINE PHOSPHATE-GUAIFENESIN
ORAL SOL 10-100mg/mL CUP 72
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