MAXIMUM STRENGTH

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-05-27
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 01:58:48

Label at a glance#

ProductMucinex Maximum Strength

Active ingredientGUAIFENESIN

Label structure11 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

Dosage and administration

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Contacts and useful links#

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 1200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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

Warnings

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; FD&C blue no. 1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-023-35

MAXIMUM STRENGTH

Mucinex®
1200 mg guaifenesin
extended-release tablets

EXPECTORANT

12
HOUR _®

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

EXTENDED-RELEASE TABLETS

full carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	16
891297	Mucinex 1200 MG 12HR Extended Release Oral Tablet	PSN	16
891297	12 HR guaifenesin 1200 MG Extended Release Oral Tablet [Mucinex]	SBD	16
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	16
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	16
891297	Mucinex 1200 MG 12 HR Extended Release Oral Tablet	SY	16

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	0363824023144	GTIN-13: 0363824023144 EAN-13: 0363824023144 GTIN-12: 363824023144 UPC-A: 363824023144 GTIN storage (14 digits): 00363824023144	63824-023 full label.jpg
QR code link	QR Code	www.mucinex.com/pages/product-faqs		63824-023 full label.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-023-02	MucinexMaximum Strength	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	16
63824-023-02	MucinexMaximum Strength	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	16
63824-023-07	MucinexMaximum Strength	7 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	7	16
63824-023-07	MucinexMaximum Strength	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	16
63824-023-18	MucinexMaximum Strength	9 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	9	16
63824-023-18	MucinexMaximum Strength	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	16
63824-023-35	MucinexMaximum Strength	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	16
63824-023-35	MucinexMaximum Strength	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	16
63824-023-36	MucinexMaximum Strength	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	16
63824-023-36	MucinexMaximum Strength	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	16
63824-023-46	MucinexMaximum Strength	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	16
63824-023-46	MucinexMaximum Strength	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	16
63824-023-48	MucinexMaximum Strength	12 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	12	16
63824-023-48	MucinexMaximum Strength	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	16
63824-023-56	MucinexMaximum Strength	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	16
63824-023-56	MucinexMaximum Strength	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-023-07	EA - Each	63824-023	28e1d815-0c0a-4cde-9c58-b42d4cdb4543	1	2015-08-04
63824-023-14	EA - Each	63824-023	5af046a6-1ef9-47f6-aab2-b208dbe48d81	1	2012-07-24
63824-023-18	EA - Each	63824-023	2691f976-8dbf-49a3-9c7b-ffaa3032e557	1	2021-04-08
63824-023-28	EA - Each	63824-023	8242604c-2af8-4a05-8c12-b974f13005e2	1	2012-07-24
63824-023-35	EA - Each	63824-023	e4523467-ea8f-4dc5-956d-3a56ebbc0c2c	1	2012-07-24
63824-023-36	EA - Each	63824-023	40a3b4a1-9bfd-45b8-b83f-cc94ecf90cd6	1	2012-07-24
63824-023-45	EA - Each	63824-023	d8efef87-b4bb-428f-bd71-fc1420a76421	1	2012-07-24
63824-023-46	EA - Each	63824-023	1af51cca-a372-4b8d-85fe-3b9cfec229aa	1	2012-07-24
63824-023-48	EA - Each	63824-023	f05af7c9-7640-4e95-b5f6-e38325371d7b	1	2012-07-24
63824-023-56	EA - Each	63824-023	b072127b-4406-4ca4-8f88-ee712d35fcb5	1	2021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	8
Guaifenesin	ACTIVE MOIETY	495W7451VQ	8
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	8
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	HHT01ZNK31	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	8
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	8
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	8

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Mucinex Maximum Strength
Guaifenesin
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-023	63824-023-07, 63824-023-35, 63824-023-36, 63824-023-48, 63824-023-46, 63824-023-18, 63824-023-02, 63824-023-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
GUAIFENESIN	495W7451VQ	ACTIB

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 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates

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 44.

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
N021282-001	MUCINEX	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-07-12
N021282-002	MUCINEX	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-12-18

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`4b0b4de00fa7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021282-001	6372252	2020-04-28	U-489			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	6372252	2020-04-28	U-489			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021282-001	6372252	2020-04-28	U-489			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	6372252	2020-04-28	U-489			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021282-001	6372252	2020-04-28	U-489			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-001	6955821	2020-04-28	U-489	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	6372252	2020-04-28	U-489			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	6955821	2020-04-28	U-489	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021282-001	6372252	2020-04-28	U-489			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	6372252	2020-04-28	U-489			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021282-001	6372252	2020-04-28	U-489			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-001	6955821	2020-04-28	U-489	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	6372252	2020-04-28	U-489			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	6955821	2020-04-28	U-489	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021282-001	6372252	2020-04-28	U-489			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-001	6955821	2020-04-28	U-489	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	6372252	2020-04-28	U-489			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	6955821	2020-04-28	U-489	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	7838032	2020-04-28		Drug product		`ea99ee380514…`

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
Mucinex Maximum Strength	GUAIFENESIN	Reckitt Benckiser LLC	47f5323c-ee3a-400d-b133-31d9c286fafd	2026-05-27	Warnings	Exact identifier ndc (package): 63824-023-07 ndc (package): 63824-023-56 ndc (package): 63824-023-46 ndc (package): 63824-023-02 ndc (package): 63824-023-48 ndc (package): 63824-023-18 ndc (package): 63824-023-36 ndc (package): 63824-023-35 ndc (product): 63824-023 ndc11 (package): 63824002318 ndc11 (package): 63824002307 ndc11 (package): 63824002336 ndc11 (package): 63824002335 ndc11 (package): 63824002346 ndc11 (package): 63824002302 ndc11 (package): 63824002348 ndc11 (package): 63824002356 spl id: 52d0f6be-a3c0-c950-e063-6294a90a5784 spl set id: 47f5323c-ee3a-400d-b133-31d9c286fafd

Reported adverse events (FAERS/openFDA)#

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