Mucolyte

Manufacturer: Rising Pharma Holdings, Inc. | Invahealth Inc.
Effective date: 2025-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:28:02

Label at a glance#

ProductMucolyte

Active ingredientGUAIFENESIN

Label structure12 sections

Contacts and useful links#

PhoneLabel contact1-844-474-7464

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5mL)

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments

OTC - QUESTIONS SECTION

Call 1-844-474-7464

OTHER SAFETY INFORMATION

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

MUCOLYTE^TM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mucolyte

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0357237359167	GTIN-13: 0357237359167 EAN-13: 0357237359167 GTIN-12: 357237359167 UPC-A: 357237359167 GTIN storage (14 digits): 00357237359167	mucolyte.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-359-12	Mucolyte	118 mL in 1 BOTTLE	LIQUID	118		1
57237-359-16	Mucolyte	473 mL in 1 BOTTLE	LIQUID	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-359-12	ML - Milliliter	57237-359	aa46343d-4ab1-42be-a72d-e8e5258dc8c0	1	2026-01-08
57237-359-16	ML - Milliliter	57237-359	faaec639-f255-498e-8333-a18d14e1f40f	1	2026-01-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Mucolyte
Guaifenesin
CITRIC ACID
FD&C RED NO. 40
GLYCERIN
MENTHOL
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM CITRATE
SODIUM SACCHARIN
SORBITOL
SUCRALOSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57237-359	57237-359-12, 57237-359-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SODIUM SACCHARIN	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
WATER	059QF0KO0R	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucolyte	GUAIFENESIN	Rising Pharma Holdings, Inc.	e4091aaf-44e3-4701-9986-aff248a2f1b8	2025-12-08	Warnings	Exact identifier ndc (package): 57237-359-16 ndc (package): 57237-359-12 ndc (product): 57237-359 ndc11 (package): 57237035912 ndc11 (package): 57237035916 spl id: ab35cca0-adaa-4e57-bd51-b29528cb8358 spl set id: e4091aaf-44e3-4701-9986-aff248a2f1b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.