FDA.reportPublic FDA data

gc 794

Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:16

Label at a glance#

ProductMUCUS RELIEF
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

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

Dosage and administration

take with full glass of water do not exceed recommended dose adults and children 12 years of age and over 1 tablet, every 4 hours, while symptoms persist • do not exceed 6 doses in 24 hours children under 12 years of age do not use

Storage and handling

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing. • store at controlled room temperature 20 °-25°C (68°-77°F)

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 make coughs more productive to rid the bronchial passageways
of bothersome mucus

Warnings

WARNINGS SECTION

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 excessive phlegm (mucus)

Stop use and ask a doctor if

  • cough lasts more than 7 days or comes back
  • cough 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with full glass of water
  • do not exceed recommended dose
adults and children 12 years
of age and over
1 tablet, every 4 hours, while
symptoms persist • do not
exceed 6 doses in 24 hours
children under 12 years of age
do not use

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

• store at controlled room temperature 20 °-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.

HOW SUPPLIED

How Supplied Section

Guaifenesin 400 mg Tablets

  • NDC 71335-1035-1: 30 Tablets in a BOTTLE
  • NDC 71335-1035-2: 20 Tablets in a BOTTLE
  • NDC 71335-1035-3: 50 Tablets in a BOTTLE
  • NDC 71335-1035-4: 60 Tablets in a BOTTLE
  • NDC 71335-1035-5: 40 Tablets in a BOTTLE

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

store at 20°-25°C(68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F).

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin 400mg Tablets

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN8
359601guaifenesin 400 MG Oral TabletSCD8

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
BarcodeData Matrix(01)00371335103514(21)0123456789(17)280417(10)208820GTIN-14: 00371335103514
GTIN-12: 371335103514
UPC-A: 371335103514
EAN-13: 0371335103514
GTIN storage (14 digits): 00371335103514		lbl713351035.jpg
Data codeCode 1287133510351lbl713351035.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
71335-1035-1MUCUS RELIEF30 in 1 BOTTLETABLET308
71335-1035-2MUCUS RELIEF20 in 1 BOTTLETABLET208
71335-1035-3MUCUS RELIEF50 in 1 BOTTLETABLET508
71335-1035-4MUCUS RELIEF60 in 1 BOTTLETABLET608
71335-1035-5MUCUS RELIEF40 in 1 BOTTLETABLET408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-794-01EA - Each57896-794381f87a8-ebdd-4389-b7c5-565cac8683b112013-08-02
57896-794-06EA - Each57896-7949cd46e8c-842e-43bc-84f6-792f6156e49512018-12-13

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
71335-103571335-1035-1, 71335-1035-2, 71335-1035-3, 71335-1035-4, 71335-1035-5
57896-794

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
ndc (package): 71335-1035-3
ndc (package): 71335-1035-4
ndc (package): 71335-1035-1
ndc (package): 71335-1035-5
ndc (package): 71335-1035-2
ndc (product): 71335-1035
ndc11 (package): 71335103502
ndc11 (package): 71335103501
ndc11 (package): 71335103505
ndc11 (package): 71335103503
ndc11 (package): 71335103504
spl id: 752e84a6-9670-4527-aacd-4ec57bc0c3c7
spl set id: 9ed5611f-4e1d-4f71-b430-a2a949bf7fe5
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
ndc (product): 57896-794

Reported adverse events (FAERS/openFDA)#

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