Mucinex

Manufacturer: REMEDYREPACK INC.
Effective date: 2020-04-06
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 23:37:23

Label at a glance#

ProductMucinex

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 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

store between 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 bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 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 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

store between 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)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Mucinex

GENERIC: Guaifenesin

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0466-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: Mucinex;600

PACKAGING: 20 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

Guaifenesin 600mg in 1

INACTIVE INGREDIENT(S):

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
ALUMINUM OXIDE
FD&C BLUE NO. 1
SODIUM STARCH GLYCOLATE TYPE A POTATO

Remedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-008-10	EA - Each	63824-008	8a8fe46e-a8dd-4e88-a43a-b5cb234a1829	1	2012-07-24
63824-008-15	EA - Each	63824-008	825a9c5e-a011-46d2-99d6-82b24621a35c	1	2012-07-24
63824-008-24	EA - Each	63824-008	72c29d28-4125-47bc-a9ec-025f76ffd696	1	2021-04-08
63824-008-27	EA - Each	63824-008	a3f2c15b-af9a-4992-9bc6-7c96ac06d528	1	2012-07-24
63824-008-32	EA - Each	63824-008	c12fa728-b6ba-4d9e-bf3c-e1fc7a5bc37c	1	2012-07-24
63824-008-34	EA - Each	63824-008	5a5a0482-291d-411b-bb0d-c85d2367ceaf	1	2012-07-24
63824-008-36	EA - Each	63824-008	25620952-bffc-449b-b2e6-ae1d2775da29	1	2015-08-04
63824-008-50	EA - Each	63824-008	e12bb389-684d-4137-99d0-3e29d2382e40	1	2012-07-24
63824-008-61	EA - Each	63824-008	ce5a1472-3ac2-498b-9b40-7c3466571b82	1	2012-07-24
63824-008-62	EA - Each	63824-008	3b8a427e-50ac-43b6-8ba5-13928b4404c3	1	2012-07-24
63824-008-69	EA - Each	63824-008	d3a2bb0a-6b5f-41cd-9303-be145966acbe	1	2012-07-24
63824-008-80	EA - Each	63824-008	04e1bccb-c1ee-4f6c-aa00-e5c02d9d5073	1	2021-04-08
63824-008-86	EA - Each	63824-008	7dec4237-179d-4a1b-a329-3781acde2238	1	2016-09-02

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Mucinex
Guaifenesin
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70518-0466	70518-0466-0
63824-008

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
GUAIFENESIN	495W7451VQ	ACTIB

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
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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 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…`
2019-12-13 00:20 UTC	2019-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex	GUAIFENESIN	Reckitt Benckiser LLC	dd379cdd-90ab-42e0-ad89-f50d3220f611	2026-05-27	Warnings	Exact identifier ndc (product): 63824-008
a29c4021-791a-e370-e053-2995a90a02ea			41265f07-29ae-45ae-ad2d-34f233fd5437	2020-04-06	Warnings	Exact identifier spl id: a29c4021-791a-e370-e053-2995a90a02ea spl set id: 41265f07-29ae-45ae-ad2d-34f233fd5437

Reported adverse events (FAERS/openFDA)#

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