Active Ingredients
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Guaifenesin And Dextromethorphan Hydrobromide Syrup
FDA Label NDC 72162-2277
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Guaifenesin And Dextromethorphan Hydrobromide (NDC 72162-2277). 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, purpose, uses, warnings, ask a doctor before use if you have, 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.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial
irritation - helps loosen phlegm (mucus) and thin bronchial secretions
to make coughs more productive
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
- cough accompanied by excessive phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days or occurs with fever, rash, or
headaches that lasts. This could be a sign of a serious condition - hypersensitive to any ingredients
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age
| adults and children 12 years and over | 2 teaspoonfuls (TSP) every 4 hours |
| children 6 to 12 years of age | 1 teaspoonful (TSP) every 4 hours |
| children under 6 years | DO NOT USE |
Tamper-Evident
Do not use if seal cap is broken or missing.
Inactive Ingredients
Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate
Other Information
- store at room temperature 20°-25°C (68°-77°F)
- each 5 mL contains: sodium 3 mg
Questions
1-877-250-3427
How Supplied
Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg.
- NDC 72162-2277-2: 237 mL in a Bottle.
Store at room temperature 20°-25°C (68°-77°F)
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Package Label.Principal Display Panel
Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL
Label (Lbl721622277)
* Please review the disclaimer below.
