Label at a glance#

ProductMucus Relief Sinus

Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Dosage and administration

• take with a full glass of water • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. • children under 12 years: do not use

Storage and handling

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number

Key Label Information#

Active Ingredients And Purpose

Active ingredients (in each immediate-release tablet)

Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Expectorant Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Warnings

Directions And Dosage

Directions

• take with a full glass of water • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. • children under 12 years: do not use

Other Label Information

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number

Inactive ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments

(800) 616-2471

Principal Display Panel

MAJOR ® NDC 0904-5792-46 Mucus Relief Sinus Guaifenesin 400 mg/ Phenylephrine HCl 10 mg Expectorant / Nasal Decongestant • Alleviates Chest Congestion • Relieves Nasal/Sinus Congestion • Does Not Contain Pseudoephedrine 30 Tablets Immediate Release TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0118E54201 Distributed by MAJOR ® PHARMACEUTICALS Repackaged By: Preferred Pharmaceuticals Inc. 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA Rev. 02/18 M-17 Re-order No. 006474 Major 44-542

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1304111	guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	2
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-7872-2	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542
68788-7872-3	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542
68788-7872-6	2023-01-30	C162847	48780-1	f386c649-f37d-0266-e053-dadaa90a7c1a	Major 44-542

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7872-2	Mucus Relief Sinus	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	2
68788-7872-3	Mucus Relief Sinus	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
68788-7872-6	Mucus Relief Sinus	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7872	MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	2	Legacy NDC, 3 package rows	20210226_a2cf1318-d2c1-4335-97d0-98e752e5649d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5792-46	EA - Each	0904-5792	765f7f44-d4d5-4630-a761-876ab4921291	1	2015-09-10
0904-5792-52	EA - Each	0904-5792	33733efc-0679-44a0-af37-0437840e0003	1	2015-09-10

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Mucus Relief Sinus
Guaifenesin and Phenylephrine HCl
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MALTODEXTRIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68788-7872	68788-7872-2, 68788-7872-3, 68788-7872-6
0904-5792

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT

Complete SPL Sections#

Complete SPL sections page 1 of 1 · 9 matching rows.

Active ingredients (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Expectorant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• take with a full glass of water • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments

OTC - QUESTIONS SECTION

(800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ® NDC 0904-5792-46 Mucus Relief Sinus Guaifenesin 400 mg/ Phenylephrine HCl 10 mg Expectorant / Nasal Decongestant • Alleviates Chest Congestion • Relieves Nasal/Sinus Congestion • Does Not Contain Pseudoephedrine 30 Tablets Immediate Release TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0118E54201 Distributed by MAJOR ® PHARMACEUTICALS Repackaged By: Preferred Pharmaceuticals Inc. 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA Rev. 02/18 M-17 Re-order No. 006474 Major 44-542

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
40560df0-8607-4b84-8989-399b97eda96b			a2cf1318-d2c1-4335-97d0-98e752e5649d	2021-02-25	Warnings	Exact identifier spl id: 40560df0-8607-4b84-8989-399b97eda96b spl set id: a2cf1318-d2c1-4335-97d0-98e752e5649d

Reported adverse events (FAERS/openFDA)#

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