FDA.reportPublic FDA data

MUCUS RELIEF

Manufacturer
YYBA CORP
Effective date
2025-11-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:18:32

Label at a glance#

ProductMUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg
Active ingredientGUAIFENESIN
Label structure11 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

GUAIFENESIN 600 MG

PURPOSE

OTC - PURPOSE SECTION

EXPECTORANT

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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 a serious illness.

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.

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

OTHER SAFETY INFORMATION

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Welmate_Mucus Relief_200ct_L7763-200-103-001b LBL_Welmate_Mucus Relief_200ct_L7763-200-103-0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 70ct tabletLabel 70ct tablet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN5
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD5
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY5

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-130373581000159GTIN-13: 0373581000159
EAN-13: 0373581000159
GTIN-12: 373581000159
UPC-A: 373581000159
GTIN storage (14 digits): 00373581000159		01b LBL_Welmate_Mucus Relief_200ct_L7763-200-103-0.jpg
BarcodeEAN-130373581000678GTIN-13: 0373581000678
EAN-13: 0373581000678
GTIN-12: 373581000678
UPC-A: 373581000678
GTIN storage (14 digits): 00373581000678		Guif-600-70.jpg

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
73581-401-02MUCUS RELIEFGUAIFENESIN EXTENDED-RELEASE 600 mg200 in 1 BOTTLETABLET2005
73581-401-20MUCUS RELIEFGUAIFENESIN EXTENDED-RELEASE 600 mg20 in 1 BOTTLETABLET205
73581-401-70MUCUS RELIEFGUAIFENESIN EXTENDED-RELEASE 600 mg70 in 1 BOTTLETABLET705

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
73581-40173581-401-02, 73581-401-70, 73581-401-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GUAIFENESIN495W7451VQACTIB

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 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
A213420-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08
A213420-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-09-14 22:38:342026-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-08-18 06:07:402026-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…

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
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgGUAIFENESINYYBA CORPd9d1ce2d-d96a-4950-e053-2995a90ad9882025-11-27WarningsExact identifier
ndc (package): 73581-401-02
ndc (package): 73581-401-20
ndc (package): 73581-401-70
ndc (product): 73581-401
ndc11 (package): 73581040102
ndc11 (package): 73581040120
ndc11 (package): 73581040170
spl id: 4497c67f-376c-7ef0-e063-6294a90ad64a
spl set id: d9d1ce2d-d96a-4950-e053-2995a90ad988

Reported adverse events (FAERS/openFDA)#

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