Dextromethorphan HBr and Guaifenesin Oral Solution DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL KESIN PHARMA CORPORATION FDA Approved Each 5 mL (1 teaspoonful) contains: Dextromethorphan Hydrobromide 10 mg Guaifenesin 100 mg Each 10 mL (2 teaspoonfuls) contains: Dextromethorphan Hydrobromide 20 mg Guaifenesin 200 mg

Drug Facts

Composition & Profile

Inactive Ingredients
Inactive Ingredients Inactive Ingredients: citric acid grape flavor methylparaben monoammonium glycrrhizate potassium citrate propylene glycol propylparaban purified water sorbitol sucralose.
Strengths
5 ml 100 unit 10 ml
Quantities
5 ml 10 ml
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
UNII
9D2RTI9KYH 495W7451VQ
Packaging

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; 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) NDC 81033-104-05; 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) NDC 81033-104-05

Package Descriptions
  • 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
  • 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) NDC 81033-104-05
  • 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) NDC 81033-104-05

Overview

Each 5 mL (1 teaspoonful) contains: Dextromethorphan Hydrobromide 10 mg Guaifenesin 100 mg Each 10 mL (2 teaspoonfuls) contains: Dextromethorphan Hydrobromide 20 mg Guaifenesin 200 mg

Indications & Usage

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

Dosage & Administration

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 Age Dose adults and children 12 years and over 10mL (2 teaspoonful) every 4 hours children 6 to under 12 years of age 5mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor

Warnings & Precautions
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.
Purpose

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

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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)

Storage & Handling

STORAGE Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

Questions

QUESTIONS OR COMMENTS QUESTIONS OR COMMENTS Call 1-833-537-4679 Packaged by: Kesin Pharma Oldsmar, FL 34677 Effective 10/2024 Revision 03 Kesin Pharma Logo


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