Dextromethorphan Hbr And Guaifenesin Oral Solution Liquid
FDA Label NDC 81033-103

15 label sections · Submitted to the FDA by Kesin Pharma Corporation · 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 Oral Solution (NDC 81033-103). 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 5 and 10 ml, description, inactive ingredients, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, 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 5 And 10 Ml

Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Inactive Ingredients

Inactive Ingredients: citric acid, grape flavor, methylparaben, monoammonium glycrrhizate, potassium citrate, propylene glycol, propylparaban,purified water, sorbitol, sucralose.

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 make coughs more productive

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 an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

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 If

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

If Pregnant Or Breast-Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA)

Directions

DIRECTIONS

Follow dosage table below or use as directed by a
physician

  • Do not take more than 6 doses in any 24-hour period

    • AgeDose
    adults and children 12 years and over10mL (2 teaspoonful) every 4 hours
    children 6 to under 12 years of age5mL (1 teaspoonful) every 4 hours
    children 2 to under 6 years of age2.5mL (1/2 teaspoonful) every 4 hours
    children under 2 yearsconsult a doctor

How Supplied

Dextromethorphan hydrobromide and Guaifenesin is a clear, grape flavor solution supplied in the following oral dosage forms:
5 mL unit dose cup:
NDC 81033-103-05
Case containing 100 units dose cups of 5 mL:
NDC 81033-103-50

10 mL unit dose cups:
NDC 81033-103-10
Case containing 100 unit dose cups of 10 mL:
NDC 81033-103-51

Questions Or Comments

QUESTIONS OR COMMENTS
Call 1-833-537-4679

Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective 10/2024
Revision 03

Principal Display Panel - 5 Ml Unit Dose Cup Label

NDC 81033-103-05

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

Principal Display Panel - 10 Ml Unit Dose Cup Label

NDC 81033-103-10

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 20mg/200mg per 10mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

* Please review the disclaimer below.