Dextromethorphan Hbr And Guaifenesin
FDA Label NDC 81033-213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Dextromethorphan Hbr And Guaifenesin (NDC 81033-213). 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 dextromethorphan hbr and guaifenesin oral solution, inactive ingredients, uses, warnings, ask a doctor before use if you have, principal display panel - 5 ml unit dose cup label, principal display panel - 10 ml unit dose cup label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Dextromethorphan Hbr And Guaifenesin Oral Solution

→ Inactive Ingredients

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Principal Display Panel - 5 Ml Unit Dose Cup Label

→ Principal Display Panel - 10 Ml Unit Dose Cup Label

Dextromethorphan Hbr And Guaifenesin Oral Solution

DM Guaifenesin
Non-Narcotic, Sugar, Dye and Alcohol Free
Expectorant/Cough Suppressant

Inactive Ingredients

Trisodium citrate Dihydrate, Citric Acid Anhydrous, USP Xanthan Gum Sodium Benzoate, NF Glycerin 99.7%, USP Propylene Glycol Sucralose Powder Sodium Saccharin, USP Sorbitol Solution 70%, Non-Crystallizable Sodium Artificial Mixed Berry Flavor Purified Water

Uses

▪ Temporarily relieves cough due to minor throat and bronchial irritations as my occur with a cold
▪ Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

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 and 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.