FDA.reportPublic FDA data

Fexofenadine Hydrochloride Tablets USP

Manufacturer
Granules India Limited
Effective date
2019-09-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:11:57

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE
Label structure2 sections

Label contents#

Full prescribing information#

Fexofenadine Hydrochloride Tablets 60 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fexo-60mg-drum-label.jpgfexo-60mg-drum-label.jpg

Fexofenadine Hydrochloride Tablets 180 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 mg180 mg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-76862207-768-85
62207-76962207-769-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FEXOFENADINEE6582LOH6VACTIB
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
STEARIC ACID4ELV7Z65APIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FEXOFENADINEE6582LOH6VACTIB
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
92737d55-7f07-50d0-e053-2a95a90ac7af66e5016b-83fb-4f49-e053-2991aa0a0e592019-09-13Exact identifier
spl id: 92737d55-7f07-50d0-e053-2a95a90ac7af
spl set id: 66e5016b-83fb-4f49-e053-2991aa0a0e59

Reported adverse events (FAERS/openFDA)#

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