Mucolyte

Mucolyte
SPL v1
SPL
SPL Set ID e4091aaf-44e3-4701-9986-aff248a2f1b8
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)
Inactive Ingredients
Citric Acid Fd&c Red No. 40 Glycerin Menthol Propylene Glycol Sodium Benzoate Sodium Citrate Sodium Saccharin Sorbitol Sucralose Water

Identifiers & Packaging

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

Active Ingredient (in each 5mL) Guaifenesin, USP 100 mg

Purpose

Expectorant

Medication Information

Warnings and Precautions

Warnings

Do not use

  • if you 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.
Purpose

Expectorant

Dosage and Administration

Directions

  • Do not take more than 6 doses in a 24-hour period
  • Do not exceed recommended dose
 adults and children 12 years and over  2 to 4 teaspoonfuls (10mL to 20mL) every 4 hours
 children under 12 years  ask a doctor

Description

Active Ingredient (in each 5mL) Guaifenesin, USP 100 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 60561-8

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

MUCOLYTETM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Drug Facts

Active Ingredient (in each 5mL)

Guaifenesin, USP 100 mg

Other Information
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.
  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate, 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.
Dosage and Administration (34068-7)

Directions

  • Do not take more than 6 doses in a 24-hour period
  • Do not exceed recommended dose
 adults and children 12 years and over  2 to 4 teaspoonfuls (10mL to 20mL) every 4 hours
 children under 12 years  ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use

  • if you 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 60561-8 (60561-8)

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

MUCOLYTETM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Purpose

Expectorant

Drug Facts

Active Ingredient (in each 5mL)

Guaifenesin, USP 100 mg

Other Information
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.
  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
Inactive Ingredients

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

Questions Or Comments (Questions or comments)

 Call 1-844-474-7464

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:52.326502 · Updated: 2026-03-14T23:11:49.333849