FDA.reportPublic FDA data

GUAIFENESIN 400MG CAPLETS

Manufacturer
Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2026-01-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:12

Label at a glance#

ProductGUAIFENESIN 400MG CAPLETS
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS. HELPS MAKE COUGHS MORE PRODUCTIVE

Dosage and administration

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST. CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

GUAIFENESIN 400MG

PURPOSE

OTC - PURPOSE SECTION

EXPECTORANT

USES

INDICATIONS & USAGE SECTION

  • HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS.
  • HELPS MAKE COUGHS MORE PRODUCTIVE

WARNINGS

WARNINGS SECTION

ASK DOCTOR BEFORE USE IF YOU HAVE:

  • PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
  • COUGH ACCOMPANIED BY EXCESSIVE PHLEGM

WHEN USING THIS PRODUCT

  • DO NOT EXCEED RECOMMENDED DOSAGE
  • DO NOT USE FOR MORE THAN 7 DAYS

STOP USE AND ASK A DOCTOR IS

  • COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

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) IMMEDIATELY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERTAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST.
  • CHILDREN UNDER 12 YEARS OF AGEDO NOT USE.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Guaifenesin_NDC 77333-360-1001b LBL_Guaifenesin_NDC 77333-360-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN7
359601guaifenesin 400 MG Oral TabletSCD7

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
BarcodeDataBar Omni(01)00377333360102GTIN-14: 00377333360102
GTIN-12: 377333360102
UPC-A: 377333360102
EAN-13: 0377333360102
GTIN storage (14 digits): 00377333360102		01b LBL_Guaifenesin_NDC 77333-360-10.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-360-102024-05-02C16284748780-11030e365-60d5-111a-e063-dadaa90a10e2GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
77333-360-102024-05-02C16284748780-11030e365-60d5-111a-e063-dadaa90a10e2GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
77333-360-102024-01-30C16284748780-11030e365-60d5-111a-e063-dadaa90a10e2GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
77333-360-102024-01-30C16284748780-11030e365-60d5-111a-e063-dadaa90a10e2GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-360-10GUAIFENESIN 400MG CAPLETS100 in 1 BOXTABLET1007
77333-360-25GUAIFENESIN 400MG CAPLETS1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-360-10EA - Each77333-36059e4bbd3-6be1-4beb-b0d0-7887c885579712022-10-06
77333-360-25EA - Each77333-3603f337a09-e952-4310-a7aa-c0fc1effdaf012022-10-06

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
77333-36077333-360-25, 77333-360-10

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-02full-release2026-06-01 01:06:26

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
GUAIFENESIN 400MG CAPLETSGUAIFENESINGendose Pharmaceuticals, LLCe7b82ec7-ef23-50c1-e053-2a95a90a662f2026-01-10WarningsExact identifier
ndc (package): 77333-360-25
ndc (package): 77333-360-10
ndc (product): 77333-360
ndc11 (package): 77333036010
ndc11 (package): 77333036025
spl id: 48032e44-d1b5-ea4d-e063-6394a90aba26
spl set id: e7b82ec7-ef23-50c1-e053-2a95a90a662f

Reported adverse events (FAERS/openFDA)#

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