Active Ingredients (In Each Teaspoonful (5 Ml))
Codeine phosphate USP 10 mg
Guaifenesin USP 100 mg
Codeine Phosphate And Guaifenesin
FDA Label NDC 70156-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Noble Pharmaceuticals, Llc for the product Codeine Phosphate And Guaifenesin (NDC 70156-112). 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, 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
* Please review the disclaimer below.
