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
Dextromethorphan Hbr. And Guaifenesin Solution
FDA Label NDC 84415-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everpharm Llc for the product Dextromethorphan Hbr. And Guaifenesin (NDC 84415-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, otc - do not use, ask a doctor before use if you have, otc - pregnancy or breast feeding, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
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
EverPharm
NDC 84415-014-01
Dextromethorphan HBr.
and Guaifenesin
Oral Solution
Cough Suppressant/
Expectorant
10 mg-100 mg/5 mL
• Alcohol Free
• Sugar Free
• Cherry Flavor
For Institutional Use Only
100 x 5 mL Unit-Dose Cups
10label (Dexguai5label)
EverPharm
NDC 84415-011-01
Dextromethorphan HBr.
and Guaifenesin
Oral Solution
Cough Suppressant/
Expectorant
20 mg-200 mg/10 mL
• Alcohol Free
• Sugar Free
• Cherry Flavor
For Institutional Use Only
100 x 10 mL Unit-Dose Cups
5label (Dexguai10label)
* Please review the disclaimer below.
