FDA Label for Siltussin Dm
View Indications, Usage & Precautions
Siltussin Dm Product Label
The following document was submitted to the FDA by the labeler of this product Tya Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))
Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoon)(TSP))
Otc - Purpose
Purpose of Guaifenesin: Expectorant
Purpose of Dextromethorphan Hydrobromide: Cough Suppressant
Indications & Usage
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
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. Do not use
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.
Otc - Keep Out Of Reach Of Children
. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
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 Ingredient
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)
Otc - Questions
888-974-5279 Questions:
Manufactured by
Silarx Pharmaceutical Inc,
1033 Stoneleigh Ave. Carmel, NY 10512
* Please review the disclaimer below.