OTC Medication Information: Siltussin DM
SILTUSSIN DM- guaifenesin and dextromethorphan hydrobromide liquid
A-S Medication Solutions
Disclaimer: 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))
Purpose of Guaifenesin: Expectorant
Purpose of Dextromethorphan Hydrobromide: Cough Suppressant
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
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 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.
Other information
store at room temperature 20°-25°C (68°-77°F)
Questions: 888-974-5279
Manufactured by
Silarx Pharmaceutical Inc,
1033 Stoneleigh Ave.
Carmel, NY 10512
HOW SUPPLIED
Product: 50090-4225
NDC: 50090-4225-0 118 mL in a BOTTLE, PLASTIC
Guaifenesin and Dextromethorphan Hydrobromide
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Labeler — A-S Medication Solutions (830016429) |
Establishment | |||
Name | Address | ID/FEI | Operations |
A-S Medication Solutions | 830016429 | RELABEL (50090-4225) |
Revised: 03/2019 A-S Medication Solutions
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.