Guaifenesin Extended-Release Tablets 600 mg and 1200 mg

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2025-10-17
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-06-01 01:39:30

Label at a glance#

ProductGuaifenesin 600 mg
Active ingredientGUAIFENESIN
Label structure13 sections

Storage and handling

Other information • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

For 600 mg:           
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg


For 1200 mg:
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

OTC - PURPOSE SECTION

Purpose

Expectorant


INDICATIONS & USAGE SECTION

Uses

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

OTC - DO NOT USE SECTION

Do not use

• for children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

For 600 mg

• 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 or 2 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


For 1200 mg

• 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 SECTION

Other information

• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
You may also report side effects to this phone number.


Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA


Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 


PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 25000-042-55
Guaifenesin Extended-Release Tablets 600 mg
20's count (2 x 10's blister) Carton


guaifenesin-600mg-blister-ifc20s
guaifenesin-600mg-blister-ifc20s


NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Label


guaifenesin-600mg-bottle-label-20s
guaifenesin-600mg-bottle-label-20s


NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Carton


 

guaifenesin-600mg-bottle-ifc-20s
guaifenesin-600mg-bottle-ifc-20s


NDC: 25000-042-12
Guaifenesin Extended-Release Tablets 600 mg
500's count Bottle Label


 

guaifenesin-600mg-bottle-label-500s
guaifenesin-600mg-bottle-label-500s

NDC: 25000-042-99

Guaifenesin Extended-Release Tablets 600 mg

40's count (2 x 20's blister) Carton


   

guaifenesin-600mg-blister-ifc-40s
guaifenesin-600mg-blister-ifc-40s

NDC: 25000-041-75
Guaifenesin Extended-Release Tablets 1200 mg
12's count (2 x 6's blister) Carton


 

guaifenesin-1200mg-12s-blisterifc
guaifenesin-1200mg-12s-blisterifc

NDC: 25000-041-12
Guaifenesin Extended-Release Tablets 1200 mg
500's count Bottle Label


guaifenesin-1200mg-bottle-label-500s
guaifenesin-1200mg-bottle-label-500s


NDC: 25000-041-34

Guaifenesin Extended-Release Tablets 1200 mg

28's count (2 x 14's blister) Carton

guaifenesin-1200mg-blisters-ifc-28sguaifenesin-1200mg-blisters-ifc-28s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN6
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN6
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD6
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD6
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY6
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130325000041120GTIN-13: 0325000041120
EAN-13: 0325000041120
GTIN-12: 325000041120
UPC-A: 325000041120
GTIN storage (14 digits): 00325000041120
guaifenesin-1200mg-bottle-label-500s.jpg
BarcodeEAN-130325000041342GTIN-13: 0325000041342
EAN-13: 0325000041342
GTIN-12: 325000041342
UPC-A: 325000041342
GTIN storage (14 digits): 00325000041342
guaifenesin-1200mg-blisters-ifc-28s.jpg
BarcodeEAN-130325000041755GTIN-13: 0325000041755
EAN-13: 0325000041755
GTIN-12: 325000041755
UPC-A: 325000041755
GTIN storage (14 digits): 00325000041755
guaifenesin-1200mg-12s-blisterifc.jpg
BarcodeEAN-130325000042011GTIN-13: 0325000042011
EAN-13: 0325000042011
GTIN-12: 325000042011
UPC-A: 325000042011
GTIN storage (14 digits): 00325000042011
guaifenesin-600mg-bottle-ifc-20s.jpg
BarcodeEAN-130325000042127GTIN-13: 0325000042127
EAN-13: 0325000042127
GTIN-12: 325000042127
UPC-A: 325000042127
GTIN storage (14 digits): 00325000042127
guaifenesin-600mg-bottle-label-500s.jpg
BarcodeEAN-130325000042554GTIN-13: 0325000042554
EAN-13: 0325000042554
GTIN-12: 325000042554
UPC-A: 325000042554
GTIN storage (14 digits): 00325000042554
guaifenesin-600mg-blister-ifc20s.jpg
BarcodeEAN-130325000042998GTIN-13: 0325000042998
EAN-13: 0325000042998
GTIN-12: 325000042998
UPC-A: 325000042998
GTIN storage (14 digits): 00325000042998
guaifenesin-600mg-blister-ifc-40s.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-041-12Guaifenesin 1200 mg500 in 1 BOTTLETABLET5006
25000-041-34Guaifenesin 1200 mg2 in 1 CARTONTABLET26
25000-041-34Guaifenesin 1200 mg14 in 1 BLISTER PACKTABLET146
25000-041-75Guaifenesin 1200 mg2 in 1 CARTONTABLET26
25000-041-75Guaifenesin 1200 mg6 in 1 BLISTER PACKTABLET66
25000-042-01Guaifenesin 600 mg20 in 1 BOTTLETABLET206
25000-042-01Guaifenesin 600 mg1 in 1 CARTONTABLET16
25000-042-12Guaifenesin 600 mg500 in 1 BOTTLETABLET5006
25000-042-55Guaifenesin 600 mg2 in 1 CARTONTABLET26
25000-042-55Guaifenesin 600 mg10 in 1 BLISTER PACKTABLET106
25000-042-99Guaifenesin 600 mg2 in 1 CARTONTABLET26
25000-042-99Guaifenesin 600 mg20 in 1 BLISTER PACKTABLET206

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-03-18full-release2026-06-01 00:59:45

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
A217780-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21
A217780-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2184e616aacf4f…
2026-09-14 22:38:342026-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…

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 1200 mgGUAIFENESIN 1200 MGMARKSANS PHARMA LIMITEDfedf43d0-d6d1-4f50-bbab-396701e45cb22025-10-17WarningsExact identifier
ndc (package): 25000-041-75
ndc (package): 25000-041-34
ndc (package): 25000-041-12
ndc (package): 25000-042-55
ndc (package): 25000-042-99
ndc (package): 25000-042-12
ndc (package): 25000-042-01
ndc (product): 25000-042
ndc (product): 25000-041
ndc11 (package): 25000004112
ndc11 (package): 25000004134
ndc11 (package): 25000004212
ndc11 (package): 25000004299
ndc11 (package): 25000004175
ndc11 (package): 25000004255
ndc11 (package): 25000004201
spl id: 0af3bdb4-c1f3-4941-a1de-6e08c49849cb
spl set id: fedf43d0-d6d1-4f50-bbab-396701e45cb2

Reported adverse events (FAERS/openFDA)#

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