FDA Label for Guaifenesin Dm
View Indications, Usage & Precautions
Guaifenesin Dm Product Label
The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. 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.
Active Ingredient (In Each 5Ml Tsp)
Dextromethorphan HBr. USP 10 mg
Guaifenesin USP 100 mg
Purpose
Cough Suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Do not useif 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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
do not take more than 6 doses in any 24 hour period
| Adults and Children 12 years of age and over | 10mL (2 teaspoonfuls every 4 hours or as directed by doctor) |
| Children under 12 years of age | Do not use |
Other Information
- store at room temperature
- 15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
- do not use if seal under cap is torn broken or missing.
Inactive Ingredients
CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE
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Product Label
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