GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 mg

Manufacturer
Walmart Stores, Inc. | Ohm Laboratories Inc.
Effective date
2022-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:34

Label at a glance#

ProductGUAIFENESIN
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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 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 (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: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release 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)
  • 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.

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 20 Extended-Release Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79903-124-20

equate™

Compare to
Mucinex®
active
ingredient*

Mucus Relief

Guaifenesin Extended-
Release Tablets, 600mg

Expectorant

  • Relieves chest congestion
  • Thins and loosens mucus

12
HOUR

600
mg

20
EXTENDED-
RELEASE
TABLETS

PRINCIPAL DISPLAY PANEL - 20 Extended-Release Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 20 Extended-Release Tablet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-124-20GUAIFENESIN1 in 1 CARTONTABLET, EXTENDED RELEASE12
79903-124-20GUAIFENESIN20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-124GUAIFENESIN TABLET, EXTENDED RELEASE [WALMART STORES, INC.]2Current NDC, Legacy NDC, 2 package rows20220513_794e383d-2cae-49d7-9c2d-ae5547bde536.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79903-124-20EA - Each79903-124a9bea69c-5e02-439f-8a64-2211f824e09f12024-03-12

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-12479903-124-20

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209254-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16
A209254-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1674a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUAIFENESINGUAIFENESINWalmart Stores, Inc.794e383d-2cae-49d7-9c2d-ae5547bde5362022-05-09WarningsExact identifier
ndc (package): 79903-124-20
ndc (product): 79903-124
ndc11 (package): 79903012420
spl id: 7e31ea24-c051-4cb3-8a94-c139820b4df3
spl set id: 794e383d-2cae-49d7-9c2d-ae5547bde536

Reported adverse events (FAERS/openFDA)#

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