GUAIFENESIN EXTENDED-RELEASE TABLETS

Manufacturer: PUBLIX SUPER MARKETS, INC | Ohm Laboratories Inc.
Effective date: 2025-05-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:01:16

Label at a glance#

ProductGuaifenesin Extended Release

Active ingredientGUAIFENESIN

Label structure10 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 between 68-77°F (20-25°C) TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 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 (1-800-222-1222).

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 between 68-77°F (20-25°C)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 1200 mg Extended-Release Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41415-997-14

12-HOUR MAXIMUM STRENGTH
mucusrelief
GUAIFENESIN EXTENDED-RELEASE
TABLETS, 1200 mg
EXPECTORANT

12 Hour

Relieves Chest Congestion
Thins and Loosens Mucus

14
EXTENDED-RELEASE
TABLETS

^†Compare to the active
ingredient of Mucinex ^®
Maximum Strength

publix-1200mg-spl-1

publix-1200mg-spl-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	2
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	2
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41415-997-14	GuaifenesinExtended Release	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1		2
41415-997-14	GuaifenesinExtended Release	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41415-997	GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [PUBLIX SUPER MARKETS, INC]	2	Current NDC, Legacy NDC, 2 package rows	20250522_038e1801-b978-4a2e-ae8c-8803596ec09c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Guaifenesin Extended Release
Guaifenesin
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
FD&C BLUE NO. 2
POVIDONE, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41415-997	41415-997-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	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 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
A209254-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2018-07-16
A209254-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-07-16

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`

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 Extended Release	GUAIFENESIN	PUBLIX SUPER MARKETS, INC	038e1801-b978-4a2e-ae8c-8803596ec09c	2025-05-20	Warnings	Exact identifier ndc (package): 41415-997-14 ndc (product): 41415-997 ndc11 (package): 41415099714 spl id: 358eee0d-f68a-daf8-e063-6394a90a4d07 spl set id: 038e1801-b978-4a2e-ae8c-8803596ec09c

Reported adverse events (FAERS/openFDA)#

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