(guaifenesin and dextromethorphan hydrobromide)
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))
Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoon)(TSP))
temporarily relieves cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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 signs of a serious condition
- hypersensitive to any ingredients
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 under 12 years||DO NOT USE|
citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.
Silarx Pharmaceutical Inc,
1033 Stoneleigh Ave.
Carmel, NY 10512
guaifenesin and dextromethorphan hydrobromide liquid
|Labeler - Silarx Pharmaceuticals,Inc (161630033)|