Drug Facts

Manufacturer
Redpharm Drug
Effective date
2026-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-11-03 06:07:13

Label at a glance#

ProductGuaifenesin 600 mg
Active ingredientGUAIFENESIN
Label structure11 sections

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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg) adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP, 600 mg (for 600mg)

Guaifenesin USP, 1200 mg (for 1200 mg)

Purpose

OTC - PURPOSE SECTION

Expectorant

Use(s)

INDICATIONS & USAGE SECTION

  • helps loosen phlegum (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 age

Ask a doctor before use if

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 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 breastfeeding,

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 aPoison 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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
  • 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 (for 1200 mg)
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Questions?

OTC - QUESTIONS SECTION

call 1-833-358-6431Monday to Friday 9:00am to 7:00pm EST

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by:

McKesson Corp., via Strategic Sourcing Services LLC.

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

Product of India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin Extended-Release Tablets600 mg

Carton Label

CartonCarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin Extended-Release Tablets1200 mg

Carton Label

CartonCarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1257-1EA - Each70677-12570eb577c9-f5fa-4f06-8e4c-948ca2c9e09e12025-05-14
70677-1257-2EA - Each70677-125710d0d3f3-5834-4df3-ad98-eb942b4dab6f12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-235167296-2351-2
70677-1257

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 45.

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
A215932-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15
A215932-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15

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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15d4dbc9d85df4…
2026-11-14 07:37:172026-10A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15d4dbc9d85df4…
2026-10-15 13:18:302026-09A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15c2088c7a36db…
2026-09-14 22:38:342026-08A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-1584e616aacf4f…
2026-08-18 06:07:402026-07A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215932-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2022-03-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A215932-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2022-03-155d02ea3f76ae…

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 600 mgGUAIFENESINStrategic Sourcing Services, LLC469c5f00-1b6c-6fc7-a352-65764ff25d452024-11-09WarningsExact identifier
ndc (product): 70677-1257

Reported adverse events (FAERS/openFDA)#

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