FDA.reportPublic FDA data

Fexofenadine HCl Tablets USP, 60 mg and 180 mg

Manufacturer
Granules India Limited
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:59

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Dosage and administration

adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

SPL UNCLASSIFIED SECTION

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

an allergic reaction to this product occurs. Seek medical help right away.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Manufactured By:
Granules India Limited
Hyderabad-500 081, India

MADE IN INDIA

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

PRINCIPAL DISPLAY PANEL 180 mg - 24s Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY
RELIEF 24HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in

Allegra ® Allergy 24 HOUR

fexo-container-labelfexo-container-label

PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-623-41
NON-DROWSY


Fexofenadine HCl
Tablets, USP

180 mg

Allergy

Antihistamine
INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

24 GELCAPS
Gel Coated Tablets

*Compare to the active ingredient in Allegra ®

Allergy 24 HOUR


fexo-container-cartonfexo-container-carton

PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-623-71
NON-DROWSY


Fexofenadine HCl Tablets USP, 180 mg

Allergy


Antihistamine


INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

70 (7x10) GELCAPS

Gel Coated Tablets


*Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR

fexo-blister-cartonfexo-blister-carton

PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-623-71
Fexofenadine HCl
Tablet USP, 180 mg
Allergy

Antihistamine (GELCAP)
Mfg. by: Granules India Limited
Made in India

M.L.No.: 37/RR/AP/2003/F/R 24 HR
Push tablet through foil

LOT#
EXP. DATE:

fexo-blister foilfexo-blister foil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-623-41Fexofenadine Hydrochloride24 in 1 CONTAINERTABLET241
62207-623-45Fexofenadine Hydrochloride225 in 1 CONTAINERTABLET2251
62207-623-57Fexofenadine Hydrochloride90 in 1 CONTAINERTABLET901
62207-623-71Fexofenadine Hydrochloride7 in 1 CARTONTABLET71
62207-623-71Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-623FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LIMITED]1Current NDC, 5 package rows20240810_1d46555d-827b-b154-e063-6294a90ad3d5.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-62362207-623-71, 62207-623-41, 62207-623-57, 62207-623-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GELATIN2G86QN327LIACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)UKE75GEA7FIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SHELLAC46N107B71OIACT
D&C RED NO. 339DBA0SBB0LIACT
AMMONIA5138Q19F1XIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18c2088c7a36db…
2026-10-15 13:18:302026-09A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18c2088c7a36db…
2026-09-14 22:38:342026-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-08-18 06:07:402026-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-184b0b4de00fa7…

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
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limited1d46555d-827b-b154-e063-6294a90ad3d52024-08-08WarningsExact identifier
ndc (package): 62207-623-71
ndc (package): 62207-623-45
ndc (package): 62207-623-57
ndc (package): 62207-623-41
ndc (product): 62207-623
ndc11 (package): 62207062371
ndc11 (package): 62207062357
ndc11 (package): 62207062341
ndc11 (package): 62207062345
spl id: 1d43d4d6-9021-eac7-e063-6294a90ad21a
spl set id: 1d46555d-827b-b154-e063-6294a90ad3d5

Reported adverse events (FAERS/openFDA)#

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