RxNorm Names
SILTUSSIN DM
(guaifenesin and dextromethorphan hydrobromide)
liquid
[Silarx Pharmaceuticals,Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7402358e-8234-472f-aa6d-cee9550662f8| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))
Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoon)(TSP))
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 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.
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 under 12 years | DO NOT USE |
Inactive ingredients
citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.
| SILTUSSIN DM
guaifenesin and dextromethorphan hydrobromide liquid |
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| Labeler - Silarx Pharmaceuticals,Inc (161630033) |
Revised: 12/2012
Document Id: 955a5379-cd94-419b-8fc1-ed582cb9645a
Set id: 7402358e-8234-472f-aa6d-cee9550662f8
Version: 13
Effective Time: 20121221
Silarx Pharmaceuticals,Inc
Review RxNorm Normal Forms