Mucolyte-dm

Mucolyte-dm
SPL v1
SPL
SPL Set ID c913d27d-bc00-4ace-9a5f-c55522e1cd1d
Route
ORAL
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Citric Acid Fd&c Red No. 40 Glycerin Menthol Propylene Glycol Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Saccharin Sorbitol Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-22

Description

Active Ingredients (in each 5 mL teaspoonful) Guaifenesin, USP 100 mg Dextromethorphan Hydrobromide, USP 10 mg


Medication Information

Warnings and 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.

Do not use if you have ever had an allergic reaction to any of the ingredients in this product.

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.

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Dosage and Administration

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
 adults and children 12 years and over  2 teaspoonfuls (10 mL)
 children under 12 years  do not use

Description

Active Ingredients (in each 5 mL teaspoonful) Guaifenesin, USP 100 mg Dextromethorphan Hydrobromide, USP 10 mg

Section 50565-1

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes

Expectorant

Cough Suppressant

Section 60561-8

*This product is neither manufactured nor distributed by the owner of the registered trademark Robitussin®-DM

MUCOLYTE-DMTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Dextromethorphan Hydrobromide, USP 10 mg

Other Information
  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
  • do not refrigerate
  • TAMPER-EVIDENT: Do not use if foil seal over bottle is torn, broken or missing
  • Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP
Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose, water.

Questions Or Comments

Call 1-844-474-7464


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Dosage and Administration (34068-7)

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
 adults and children 12 years and over  2 teaspoonfuls (10 mL)
 children under 12 years  do not use

Warnings and Precautions (34071-1)

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.

Do not use if you have ever had an allergic reaction to any of the ingredients in this product.

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.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Expectorant

Cough Suppressant

Section 60561-8 (60561-8)

*This product is neither manufactured nor distributed by the owner of the registered trademark Robitussin®-DM

MUCOLYTE-DMTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Dextromethorphan Hydrobromide, USP 10 mg

Other Information
  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
  • do not refrigerate
  • TAMPER-EVIDENT: Do not use if foil seal over bottle is torn, broken or missing
  • Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP
Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose, water.

Questions Or Comments (Questions or comments)

Call 1-844-474-7464


Advanced Ingredient Data


Raw Label Data

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