Mucus Relief

Manufacturer: RedPharm Drug
Effective date: 2024-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:16:07

Label at a glance#

ProductMucus Relief

Active ingredientGUAIFENESIN

Label structure15 sections

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. store between 20 to 25°C (68 to 77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg

PURPOSE

OTC - PURPOSE SECTION

Expectorant

USE(S)

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

IF PREGNANT OR BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for the timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours.
Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

OTHER INFORMATION

STORAGE AND HANDLING SECTION

tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing.
store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

SPL UNCLASSIFIED SECTION

1-800-616-2471

You may also report side effects to this phone number.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®
NDC 0904-6986-40
Compare to the active ingredient in Mucinex® Extended Release 600 mg Tablets*

MUCUS RELIEF

Guaifenesin Extended-Release Tablets, 600 mg

EXPECTORANT
12 HOUR

Relieves Chest Congestion

Thins and Loosens Mucus

500 EXTENDED-RELEASE TABLETS

233

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EPM LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	5
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	5
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1804-7	2024-07-25	C162847	48780-1	1030e365-673e-111a-e063-dadaa90a10e2	MUCUS RELIEF 600mg
67296-1804-7	2024-01-30	C162847	48780-1	1030e365-673e-111a-e063-dadaa90a10e2	MUCUS RELIEF 600mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1804-7	Mucus Relief	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1804	MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [REDPHARM DRUG]	5	Legacy NDC, 1 package rows	20240727_b2e85973-2179-5a21-e053-2a95a90ad6bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6986-40	EA - Each	0904-6986	78a8eee7-3b8c-45a3-996f-e9179784b189	1	2019-10-07

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Mucus Relief
Guaifenesin
HYPROMELLOSE, UNSPECIFIED
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67296-1804	67296-1804-7
0904-6986

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
GUAIFENESIN	495W7451VQ	ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209215-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2017-09-06
A209215-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2017-09-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief	GUAIFENESIN	Major Pharmaceuticals	4d98920b-caf7-42d9-bd08-859d27b6d76a	2025-11-24	Warnings	Exact identifier ndc (product): 0904-6986
1e1e00e5-8c0b-7347-e063-6394a90a2a40			b2e85973-2179-5a21-e053-2a95a90ad6bb	2024-07-25	Warnings	Exact identifier spl id: 1e1e00e5-8c0b-7347-e063-6394a90a2a40 spl set id: b2e85973-2179-5a21-e053-2a95a90ad6bb

Reported adverse events (FAERS/openFDA)#

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