FDA.reportPublic FDA data

Mucus Relief

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:20:26

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure10 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 tablet every 12 hours. Do not exceed 2 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 1200 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

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) 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

• store between 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.gencare.health

NDC 72090-012-02 (30ct HDPE Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0183-01 GC Mucus Relief 1200mg 30ct_page-0001PL0183-01 GC Mucus Relief 1200mg 30ct_page-0001

NDC 72090-012-03 (50ct HDPE Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0184-02 GC Mucus Relief 1200mg 50ct_page-0001PL0184-02 GC Mucus Relief 1200mg 50ct_page-0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY1

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-130372090002906GTIN-13: 0372090002906
EAN-13: 0372090002906
GTIN-12: 372090002906
UPC-A: 372090002906
GTIN storage (14 digits): 00372090002906		PL0183-01 GC Mucus Relief 1200mg 30ct_page-0001.jpg
BarcodeEAN-130372090002913GTIN-13: 0372090002913
EAN-13: 0372090002913
GTIN-12: 372090002913
UPC-A: 372090002913
GTIN storage (14 digits): 00372090002913		PL0184-02 GC Mucus Relief 1200mg 50ct_page-0001.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
72090-012-01Mucus Relief100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
72090-012-02Mucus Relief30 in 1 BOTTLETABLET, EXTENDED RELEASE301
72090-012-03Mucus Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE501

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
72090-01272090-012-02, 72090-012-03, 72090-012-01

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
GUAIFENESIN495W7451VQACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08c2088c7a36db…
2026-10-15 13:18:302026-09A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08c2088c7a36db…
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…

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 ReliefGUAIFENESINPioneer Life Sciences, LLCd635b228-a51f-42d9-885c-3cd566fd352b2025-12-04WarningsExact identifier
ndc (package): 72090-012-02
ndc (package): 72090-012-01
ndc (package): 72090-012-03
ndc (product): 72090-012
ndc11 (package): 72090001203
ndc11 (package): 72090001201
ndc11 (package): 72090001202
spl id: 022e6fd9-1e64-4364-a117-67354fed2fa0
spl set id: d635b228-a51f-42d9-885c-3cd566fd352b

Reported adverse events (FAERS/openFDA)#

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