MUCUS RELIEF Guaifenesin Extended-Release Tablets 600 mg

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:28

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure13 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 seal on the bottle printed "SEALED for YOU PROTECTION" 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

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.

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 seal on the bottle printed "SEALED for YOU PROTECTION" 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

1-800-616-2471

You may also report side effects to this phone number. 

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1280904698640guaifenesin-er-tabs-8637-1.jpg
Data codeCode 128090469864039guaifenesin-er-tabs-8637-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6986-40EA - Each0904-698678a8eee7-3b8c-45a3-996f-e9179784b18912019-10-07

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
0615-86370615-8637-39
0904-6986

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINNCS HealthCare of KY, LLC dba Vangard Labs41f4f8df-87d4-459f-af6d-3a4356a8115b2026-06-04WarningsExact identifier
ndc (package): 0615-8637-39
ndc (product): 0615-8637
ndc11 (package): 00615863739
spl id: 364f94ae-e176-4547-8aa1-209ac63d9ef4
spl set id: 41f4f8df-87d4-459f-af6d-3a4356a8115b
Mucus ReliefGUAIFENESINMajor Pharmaceuticals4d98920b-caf7-42d9-bd08-859d27b6d76a2025-11-24WarningsExact identifier
ndc (product): 0904-6986

Reported adverse events (FAERS/openFDA)#

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