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

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 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, otc - active ingredient, inactive ingredients, uses, warnings, ask a doctor before use if you have, otc - stop use, otc - pregnancy 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

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

Otc - Active Ingredient

Active Ingredients – 5mL (1 teaspoonful) Purposes
Guaifenesin 100 mg Expectorant
Dextromethorphan 5 mg Cough Suppressant

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.

Otc - Stop Use

  • 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Dosage & Administration

Directions
▪ 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

Otc - Questions

QUESTIONS OR COMMENTS
Call 1-833-537-4679

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)

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