Guaifenesin Extended-Release Tablets 600mg and 1200mg

Manufacturer: Granules India Ltd
Effective date: 2026-10-07
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: daily-update
Hydrated at: 2026-10-10 01:02:56

Label at a glance#

ProductGUAIFENESIN

Active ingredientGUAIFENESIN

Label structure13 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 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(For 600mg) adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg) children under 12 years of age: do no...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-770-3183

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 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

WARNINGS

WARNINGS SECTION

Do not use

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 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.

PREGNANCY/BREASTFEEDING

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 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(For 600mg)
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
children under 12 years of age: do not use

OTHER INFORMATION

WARNINGS SECTION

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
store between 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin-ER-1200-mg-bulk-label

62207-570-31.jpg

70010-569-99.jpg

70010-570-30

70010-570-92.jpg

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)50362207570300(17)000000(10)XXXXXXX	GTIN-14: 50362207570300 GTIN storage (14 digits): 50362207570300	62207-570-30.jpg
Data code	Code 128	(00)189038320000000004		62207-570-30.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

Products#

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

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

GUAIFENESIN
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62207-569	62207-569-99, 62207-569-93
62207-570	62207-570-92, 62207-570-30, 62207-570-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
GUAIFENESIN	495W7451VQ	ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2025-10-16	full-release	2026-06-01 01:39:23
5	2023-01-31	full-release	2026-05-31 23:53:36

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
A213420-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2020-05-08
A213420-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-05-08

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 2 · 78 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	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`

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
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ba7c1e26-b7d0-4aea-e053-2a95a90a903e	2025-10-16	Warnings	Exact identifier ndc (package): 62207-570-30 ndc (package): 62207-570-92 ndc (package): 62207-570-31 ndc (package): 62207-569-93 ndc (package): 62207-569-99 ndc (product): 62207-569 ndc (product): 62207-570 ndc11 (package): 62207056999 ndc11 (package): 62207057031 ndc11 (package): 62207057030 ndc11 (package): 62207056993 ndc11 (package): 62207057092 spl set id: ba7c1e26-b7d0-4aea-e053-2a95a90a903e

Reported adverse events (FAERS/openFDA)#

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