Guaifenesin

Manufacturer
Ohm Laboratories, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:44:18

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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 over 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 store between 20-25°C (68-77°F) TAMPER EVI...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Guaifenesin, USP

Purpose

OTC - PURPOSE SECTION

Expectorant

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).

Uses

INDICATIONS & USAGE SECTION

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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

  • 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

  • cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache.
  • These could be signs of serious illness.

If pregnant or breast-feeding,ask a health professional before use.

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 over 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

  • 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

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

Keep the carton. It contains important information. See end panel for expiration date.

†OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901


PRODUCT OF INDIA


R0425

CODE No.: PB/DRUGS/1809-0SP

Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

spl-guaifenesin-ohmspl-guaifenesin-ohm

Principal Display Panel - Guaifenesin ER Tablets, 1200 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

spl-guaifenesin-ohm2spl-guaifenesin-ohm2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN4
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN4
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD4
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD4
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY4
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4

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
51660-566-21Guaifenesin20 in 1 CARTONTABLET, EXTENDED RELEASE204
51660-566-41Guaifenesin40 in 1 CARTONTABLET, EXTENDED RELEASE404
51660-566-68Guaifenesin68 in 1 CARTONTABLET, EXTENDED RELEASE684
51660-567-54Guaifenesin14 in 1 CARTONTABLET, EXTENDED RELEASE144
51660-567-58Guaifenesin56 in 1 CARTONTABLET, EXTENDED RELEASE564
51660-567-86Guaifenesin28 in 1 CARTONTABLET, EXTENDED RELEASE284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-566-21EA - Each51660-5664620bf8a-cf82-4184-a8c7-09086b0012f512023-08-08
51660-567-86EA - Each51660-567f0b32da4-bab4-45e9-be5c-a1d7d159d4ef12025-09-12

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
51660-56651660-566-41, 51660-566-21, 51660-566-68
51660-56751660-567-54, 51660-567-86, 51660-567-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A209254-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A209254-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-16c2088c7a36db…
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…

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
GuaifenesinGUAIFENESINOhm Laboratories, Inc.7076e42a-17ff-4c42-9963-2dc02c0a5e492026-02-12WarningsExact identifier
ndc (package): 51660-567-86
ndc (package): 51660-567-54
ndc (package): 51660-566-41
ndc (package): 51660-566-68
ndc (package): 51660-567-58
ndc (package): 51660-566-21
ndc (product): 51660-566
ndc (product): 51660-567
ndc11 (package): 51660056758
ndc11 (package): 51660056641
ndc11 (package): 51660056621
ndc11 (package): 51660056786
ndc11 (package): 51660056668
ndc11 (package): 51660056754
spl id: 4aa4fb35-6f33-6e33-e063-6394a90a495e
spl set id: 7076e42a-17ff-4c42-9963-2dc02c0a5e49

Reported adverse events (FAERS/openFDA)#

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