FDA.reportPublic FDA data

Fexofenadine HCl Tablets USP, 60 mg and 180 mg

Manufacturer
Granules India Limited | GRANULES LIFE SCIENCES PRIVATE LIMITED
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-18 05:10:11

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Dosage and administration

adults and children 12 years of age and over  take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg) take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)   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, 60 mg (for 60 mg)

Fexofenadine HCl USP, 180 mg (for 180 mg)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

WARNINGS SECTION

Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:

  • trouble swallowing 
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • wheezing or problems breathing
  • drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

OTC - DO NOT USE SECTION

  •  to preventhives from any known cause such as:
  • foods
  • insect stings
  • medicines
  • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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 60 mg - 10s Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-889-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 60 mg

Hives

Antihistamine

REDUCES HIVES and            12 HR

RELIEVES ITCHING

due to hives

 

10 Tablets

*Compare to the active ingredient in

Allegra ®Hives 12 HOUR 

fexofenadine-60mg-10s-labelfexofenadine-60mg-10s-label

PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-889-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

60 mg

 Hives

Antihistamine

REDUCES HIVES and            

RELIEVES ITCHING

due to hives

                                             12 HR

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 12 HOUR


fexofenadine-60mg-10s-carton
fexofenadine-60mg-10s-carton

PRINCIPAL DISPLAY PANEL 60 mg - Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-889-60               

                                                                                  New!

                                                                NON-DROWSY

Fexofenadine HCl Tablets USP, 60 mg

 Hives

Antihistamine

REDUCES HIVES and                           12 HR

RELIEVES ITCHING

due to hives

                              

                                                                         72 (8 x 9) Tablets

*Compare to the active ingredient in Allegra ® Hives 12 HOUR


fexofenadine-60mg-blister-cartonfexofenadine-60mg-blister-carton

PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-891-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 180 mg

Hives

Antihistamine

REDUCES HIVES and           24 HR

RELIEVES ITCHING

due to hives

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR 


fexofenadine-180mg-10s-labelfexofenadine-180mg-10s-label

PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-891-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

180 mg

Hives

Antihistamine

REDUCES HIVES and             24 HR

RELIEVES ITCHING

due to hives

                                              

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR


fexofenadine-180mg-10s-carton
fexofenadine-180mg-10s-carton

PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-891-58                                              New!

                                                            NON-DROWSY

Fexofenadine HCl Tablets USP, 180 mg

Hives

Antihistamine

 

REDUCES HIVES and                         24 HR

RELIEVES ITCHING

due to hives

 

                                                             70 (7 x 10) Tablets

*Compare to the active ingredient in Allegra ® Hives 24 HOUR 


fexofenadine-180mg-blister-cartonfexofenadine-180mg-blister-carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130362207889513GTIN-13: 0362207889513
EAN-13: 0362207889513
GTIN-12: 362207889513
UPC-A: 362207889513
GTIN storage (14 digits): 00362207889513		fexofenadine-60mg-10s-carton.jpg
BarcodeEAN-130362207889605GTIN-13: 0362207889605
EAN-13: 0362207889605
GTIN-12: 362207889605
UPC-A: 362207889605
GTIN storage (14 digits): 00362207889605		fexofenadine-60mg-blister-carton.jpg
BarcodeEAN-130362207891516GTIN-13: 0362207891516
EAN-13: 0362207891516
GTIN-12: 362207891516
UPC-A: 362207891516
GTIN storage (14 digits): 00362207891516		fexofenadine-180mg-10s-carton.jpg
BarcodeEAN-130362207891585GTIN-13: 0362207891585
EAN-13: 0362207891585
GTIN-12: 362207891585
UPC-A: 362207891585
GTIN storage (14 digits): 00362207891585		fexofenadine-180mg-blister-carton.jpg

DailyMed Product Concepts#

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

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-88962207-889-51, 62207-889-49, 62207-889-60
62207-89162207-891-51, 62207-891-49, 62207-891-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (15 MPA.S)36SFW2JZ0WIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (15 MPA.S)36SFW2JZ0WIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-02full-release2026-06-01 01:19:10

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 Limitede0537b71-fdee-4122-9c09-868ce73520802026-06-15WarningsExact identifier
ndc (package): 62207-891-49
ndc (package): 62207-889-51
ndc (package): 62207-891-51
ndc (package): 62207-889-60
ndc (package): 62207-891-58
ndc (package): 62207-889-49
ndc (product): 62207-889
ndc (product): 62207-891
ndc11 (package): 62207089151
ndc11 (package): 62207088951
ndc11 (package): 62207089158
ndc11 (package): 62207089149
ndc11 (package): 62207088960
ndc11 (package): 62207088949
spl id: 5447e2c4-49cb-5f8d-e063-6294a90a2457
spl set id: e0537b71-fdee-4122-9c09-868ce7352080

Reported adverse events (FAERS/openFDA)#

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