Dextromethorphan Hbr And Guaifenesin Oral Solution
284eae44-81bc-400c-e063-6394a90af446
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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Source: dailymed · Ingested: 2026-02-15T12:05:27.551415 · Updated: 2026-03-14T23:07:17.257844