Dextromethorphan Hbr. And Guaifenesin Solution
FDA Label NDC 57237-313

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Dextromethorphan Hbr. And Guaifenesin (NDC 57237-313). 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

→ 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

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