FDA.reportPublic FDA data

Refenesen Mucus Relief

Manufacturer
Reese Pharmaceutical Co
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:45

Label at a glance#

ProductRefenesen Mucus Relief
Active ingredientGuaifenesin
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed Children under 6 years of age: consult a doctor     Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Storage and handling

store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active ingredient (per tablet)

Guaifenesin  400mg

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 
  • helps make coughs more productive

Warnings

WARNINGS SECTION

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other directions

STORAGE AND HANDLING SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin,  Stearic acid, Povidone K30, Povidone 90F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN4
359601guaifenesin 400 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

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
10956-845-30Refenesen Mucus Relief1 in 1 CARTONTABLET14
10956-845-30Refenesen Mucus Relief30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-845REFENESEN MUCUS RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]4Current NDC, Legacy NDC, 2 package rows20241220_861dffb7-8bf4-4f03-bcc2-ed8a35bc341d.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10956-84510956-845-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
MALTODEXTRIN7CVR7L4A2DIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE K30U725QWY32XIACT
POVIDONE K90RDH86HJV5ZIACT

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
Refenesen Mucus ReliefGUAIFENESINReese Pharmaceutical Co861dffb7-8bf4-4f03-bcc2-ed8a35bc341d2024-12-18WarningsExact identifier
ndc (package): 10956-845-30
ndc (product): 10956-845
ndc11 (package): 10956084530
spl id: 425102a9-bdd6-4b48-8758-503659b1b7b9
spl set id: 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d

Reported adverse events (FAERS/openFDA)#

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