Active Ingredients (In Each 5 Ml = 1 Tsp)
Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 mg
Guaifenesin And Codeine Phosphate
FDA Label NDC 54868-4768
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Guaifenesin And Codeine Phosphate (NDC 54868-4768). 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 5 ml = 1 tsp), 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
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- calms the cough control center and relieves coughing
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 hours
- do not take more than 6 doses in any 24-hour period
adults and children 12 years and over | take 10 mL (2 tsp) |
children 6 years to under 12 years | take 5 mL (1 tsp) |
children 2 years to under 6 years | consult a doctor |
children under 2 years | do not use |
Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Other Information
store at 15° to 30°C (59° to 86°F)
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredients
alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Principal Display Panel
Guaifenesin and Codeine Phosphate Syrup SF100/10 mg (118 mL)NDC 54868-4768-0
* Please review the disclaimer below.
