Dextromethorphan Hbr And Guaifenesin Oral Solution

Dextromethorphan Hbr And Guaifenesin Oral Solution
SPL v3
SPL
SPL Set ID 284eae44-81bc-400c-e063-6394a90af446
Route
ORAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Propylene Glycol Anhydrous Citric Acid Propylparaben Water Sucralose Methylparaben Sorbitol Potassium Citrate Ammonium Glycyrrhizate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02

Description

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

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


Medication Information

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

Description
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

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
Storage

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

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.

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

Inactive Ingredients

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

Questions Or Comments

QUESTIONS OR COMMENTS

Call 1-833-537-4679

Packaged by:

Kesin Pharma


Oldsmar, FL 34677

Effective 10/2024

Revision 03

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)

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.
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)

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


Structured Label Content

Uses (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
Storage (STORAGE)

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

Warnings (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.

Directions (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

Description (DESCRIPTION)
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

How Supplied (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

Inactive Ingredients

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

Questions Or Comments (QUESTIONS OR COMMENTS)

QUESTIONS OR COMMENTS

Call 1-833-537-4679

Packaged by:

Kesin Pharma


Oldsmar, FL 34677

Effective 10/2024

Revision 03

Stop Use and Ask A Doctor If (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)

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

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)

Ask A Doctor Before Use If You Have (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.
Principal Display Panel 5 Ml Unit Dose Cup Label (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 (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)

Dextromethorphan Hbr and Guaifenesin Oral Solution 5 and 10 Ml (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


Advanced Ingredient Data


Raw Label Data

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