Mucus Relief Guaifenesin Extended-Release Tablets 600 mg

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2022-01-06
Label type: Human OTC Drug Label
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:19:01

Label at a glance#

ProductGuaifenesin Extended Release 600 mg

Active ingredientGUAIFENESIN

Label structure14 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 to 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-609-860-2600

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 A ASK 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 to 2 tablets every 12 hours.
Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

tamper evident: do not use if carton is open or if printed seal on blister 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

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62011-0382-1

HealthMart
Compare to Mucinex Extended Release 600mg Tablets Active Ingredient*

12 HOUR

Mucus Relief

Guaifenesin Extended-Release Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

40 EXTENDED-RELEASE TABLETS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0382	GUAIFENESIN EXTENDED RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]	5	Legacy NDC	20220107_d2c4ea2f-dbdc-40e1-96df-a0193560e9ea.zip

Products#

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

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

Guaifenesin Extended Release 600 mg
Guaifenesin
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
HYPROMELLOSE 2208 (100000 MPA.S)
MICROCRYSTALLINE CELLULOSE
POVIDONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62011-0382	62011-0382-1

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
GUAIFENESIN	495W7451VQ	ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	IACT
HYPROMELLOSE 2208 (100000 MPA.S)	VM7F0B23ZI	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
14f81b03-950e-4d2f-a194-a461b9267127			d2c4ea2f-dbdc-40e1-96df-a0193560e9ea	2025-12-01	Warnings	Exact identifier spl set id: d2c4ea2f-dbdc-40e1-96df-a0193560e9ea

Reported adverse events (FAERS/openFDA)#

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