FDA Label for Dextromethorphan Hbr. And Guaifenesin
View Indications, Usage & Precautions
Dextromethorphan Hbr. And Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. 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.
Drug Facts
10 mg-100 mg/5 mL -
Active ingredient per 5 mL (1 unit dose)
Dextromethorphan HBr. 10 mg
Guaifenesin 100 mg
20 mg-200 mg/10 mL -
Active ingredient per 10 mL (1 unit dose)
Dextromethorphan HBr. 20 mg
Guaifenesin 200 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
Otc - Do Not Use
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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
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)
Package Label.Principal Display Panel
10 mg-100 mg/5 mL
Lid Label NDC 57237-312-05
Case Label NDC 57237-312-51
20 mg-200 mg/10 mL
Lid Label NDC 57237-313-01
Case Label NDC 57237-313-18
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