FDA.reportPublic FDA data

MUCUS RELIEF- Guaifenesin 400 mg tablet

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:35

Label at a glance#

ProductMUCUS RELIEF
Active ingredientGUAIFENESIN
Label structure15 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 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 makes coughs more productive

Warnings

WARNINGS SECTION

Do not use: 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 is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • Adults and children 12 years and older:take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years:do not use

Other information

OTHER SAFETY INFORMATION

  • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • Keep in a dry place and do not expose to heat
  • Read all product information before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

Maltodextrin, Povidone, Silicon dioxide, Stearic acid.

Questions or Comments ?

OTC - QUESTIONS SECTION

Call +1 (732) 994-2808 or email support@gencare.health

SPL UNCLASSIFIED SECTION

This product is not manufcatured or distributed by Reckitt Benckiser's , owner of the Registered Trademark MUCINEX®

SPL UNCLASSIFIED SECTION

Distributed by: GenCare Consumer Products, LLC

40E Cotters Ln Suite A, East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0228-00 Mucus Relief Regular Strength 200ctPL0228-00 Mucus Relief Regular Strength 200ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN2
359601guaifenesin 400 MG Oral TabletSCD2

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
Data codeCode 128X002I3J0EFPL0228-00 Mucus Relief Regular Strength 200ct.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
72090-035-01MUCUS RELIEF200 in 1 BOTTLETABLET2002

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
72090-03572090-035-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
POVIDONEFZ989GH94EIACT
MALTODEXTRIN7CVR7L4A2DIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

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 RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f2025-12-26WarningsExact identifier
ndc (package): 72090-035-01
ndc (product): 72090-035
ndc11 (package): 72090003501
spl id: b3622624-6b61-4dbc-95ed-9ba2155ecc34
spl set id: 0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f

Reported adverse events (FAERS/openFDA)#

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