Guaifenesin Extended Release Tablets 600 mg and 1200 mg

Manufacturer
Guardian Drug Company
Effective date
2018-02-28
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:44

Label at a glance#

ProductGuaifenesin Extended-Release 600 mg
Active ingredientGUAIFENESIN
Label structure28 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 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

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)

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 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

  • 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.

ACTIVE INGREDIENT (in each extended-release tablet)

SPL UNCLASSIFIED SECTION

Guaifenesin 1200 mg  

PURPOSE

SPL UNCLASSIFIED SECTION

Expectorant

USE(S)

SPL UNCLASSIFIED SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

SPL UNCLASSIFIED SECTION

.

DO NOT USE

SPL UNCLASSIFIED SECTION

for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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,

SPL UNCLASSIFIED SECTION

ask a health professional before use. 

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

SPL UNCLASSIFIED 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 tablet every 12 hours.  
  • Do not exceed 2 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 600 MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53041-233-32

GUARDIAN

12 HOUR

Guaifenesin

Extended-Release

Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS

600600

PRINCIPAL DISPLAY PANEL 1200 MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53041-234-58

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Guaifenesin

Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucuc

14 EXTENDED-RELEASE TABLETS

12001200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN2
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2
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
53041-233-30Guaifenesin Extended-Release 600 mg1 in 1 CARTONTABLET, EXTENDED RELEASE12
53041-233-30Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
53041-233-32Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
53041-233-32Guaifenesin Extended-Release 600 mg2 in 1 CARTONTABLET, EXTENDED RELEASE22
53041-233-38Guaifenesin Extended-Release 600 mg4 in 1 CARTONTABLET, EXTENDED RELEASE42
53041-233-38Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
53041-234-37Guaifenesin Extended-Release 1200 mg4 in 1 CARTONTABLET, EXTENDED RELEASE42
53041-234-37Guaifenesin Extended-Release 1200 mg7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE72
53041-234-47Guaifenesin Extended-Release 1200 mg7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE72
53041-234-47Guaifenesin Extended-Release 1200 mg6 in 1 CARTONTABLET, EXTENDED RELEASE62
53041-234-58Guaifenesin Extended-Release 1200 mg7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE72
53041-234-58Guaifenesin Extended-Release 1200 mg2 in 1 CARTONTABLET, EXTENDED RELEASE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-233GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE GUAIFENESIN EXTENDED-RELEASE 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY]2Current NDC, Legacy NDC, 6 package rows20180301_20f9e083-419d-429d-a570-24b312ed5d2a.zip
53041-234GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE GUAIFENESIN EXTENDED-RELEASE 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY]2Current NDC, Legacy NDC, 6 package rows20180301_20f9e083-419d-429d-a570-24b312ed5d2a.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-23353041-233-32, 53041-233-30, 53041-233-38
53041-23453041-234-58, 53041-234-37, 53041-234-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 44.

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
A209215-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06
A209215-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06c2088c7a36db…
2026-10-15 13:18:302026-09A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06c2088c7a36db…
2026-09-14 22:38:342026-08A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0684e616aacf4f…
2026-09-14 22:38:342026-08A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0684e616aacf4f…
2026-08-18 06:07:402026-07A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-064b0b4de00fa7…

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
Guaifenesin Extended-Release 600 mgGUAIFENESINGuardian Drug Company20f9e083-419d-429d-a570-24b312ed5d2a2018-02-28WarningsExact identifier
ndc (package): 53041-233-38
ndc (package): 53041-233-32
ndc (package): 53041-233-30
ndc (package): 53041-234-47
ndc (package): 53041-234-58
ndc (package): 53041-234-37
ndc (product): 53041-234
ndc (product): 53041-233
ndc11 (package): 53041023437
ndc11 (package): 53041023447
ndc11 (package): 53041023338
ndc11 (package): 53041023330
ndc11 (package): 53041023458
ndc11 (package): 53041023332
spl id: 8186c3e8-1ae5-459d-8771-ad2d1ae95387
spl set id: 20f9e083-419d-429d-a570-24b312ed5d2a

Reported adverse events (FAERS/openFDA)#

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