Major 44-542

Manufacturer: Preferred Pharmaceuticals, Inc.
Effective date: 2019-11-01
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:01:22

Label at a glance#

ProductSinus Congestion PE

Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure8 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

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

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 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	4
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	4

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
68788-0845-2	2021-01-29	C162847	48780-1	ba0f9c33-342c-a910-e053-dadaa90a0b85	Major 44-542
68788-0845-3	2021-01-29	C162847	48780-1	ba0f9c33-342c-a910-e053-dadaa90a0b85	Major 44-542
68788-0845-6	2021-01-29	C162847	48780-1	ba0f9c33-342c-a910-e053-dadaa90a0b85	Major 44-542

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-0845-2	Sinus Congestion PE	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	4
68788-0845-3	Sinus Congestion PE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	4
68788-0845-6	Sinus Congestion PE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0845	SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4	Legacy NDC, 3 package rows	20191102_31257238-a0b0-4f2c-98ea-c24b8a6dc30a.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68788-0845	68788-0845-2, 68788-0845-3, 68788-0845-6
0904-5792

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Complete SPL Sections#

Complete SPL sections page 1 of 1 · 8 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

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 186 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii candidate 15 equally ranked IID candidates

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
e7dcab6d-10d0-4f5d-b0f7-edfb142f815a			31257238-a0b0-4f2c-98ea-c24b8a6dc30a	2019-11-01	Warnings	Exact identifier spl id: e7dcab6d-10d0-4f5d-b0f7-edfb142f815a spl set id: 31257238-a0b0-4f2c-98ea-c24b8a6dc30a

Reported adverse events (FAERS/openFDA)#

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