FDA.reportPublic FDA data

Family Wellness Chest Congestion Relief

Manufacturer
Family Dollar Services Inc | Reese Pharmaceutical Co | Pharbest
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:44:36

Label at a glance#

ProductFamily Wellness Chest Congestion 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. Do not exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours. Children under 6 years of age: consult 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)

OTC - STOP USE SECTION

Stop use and ask doctor if

  • 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.

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 immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed. Do not exceed 6 tablets in 24 hours.
  • Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: consult a doctor    

Other Information

STORAGE AND HANDLING SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose, silicon dioxide, povidone K30, povidone 90F, maltodextrin, stearic acid.

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 TabletPSN5
359601guaifenesin 400 MG Oral TabletSCD5

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
55319-891-30Family Wellness Chest Congestion Relief30 in 1 BOTTLETABLET305
55319-891-30Family Wellness Chest Congestion Relief1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-891FAMILY WELLNESS CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [FAMILY DOLLAR SERVICES INC]5Current NDC, 2 package rows20241220_412f3459-4c22-4822-86bd-011fc3e91ca6.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
55319-89155319-891-30

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
COPOVIDONED9C330MD8BIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE K90RDH86HJV5ZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
Family Wellness Chest Congestion ReliefGUAIFENESINFamily Dollar Services Inc412f3459-4c22-4822-86bd-011fc3e91ca62024-12-18WarningsExact identifier
ndc (package): 55319-891-30
ndc (product): 55319-891
ndc11 (package): 55319089130
spl id: 6eaa5b33-e190-4039-877d-70b6cf863d6c
spl set id: 412f3459-4c22-4822-86bd-011fc3e91ca6

Reported adverse events (FAERS/openFDA)#

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