MUCOLYTE- guaifenesin liquid

Mucolyte by

Drug Labeling and Warnings

Mucolyte by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Invahealth Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each 5mL)

Guaifenesin, USP 100 mg

Purpose

Expectorant

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

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.

PREGNANCY 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.

DOSAGE & 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

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

OTHER SAFETY INFORMATION

*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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCOLYTE 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-359
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-359-12	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2025
2	NDC: 57237-359-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/22/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Invahealth Inc. (116840615)

Establishment
Name	Address	ID/FEI	Business Operations
Invahealth Inc.		116840615	manufacture(57237-359) , analysis(57237-359)