Fexofenadine HCl Tablets USP, 60 mg and 180 mg

Manufacturer
Granules India Ltd | GRANULES LIFE SCIENCES PRIVATE LIMITED
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-06-18 05:10:11

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 sections

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(S)

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

USE(S)

INDICATIONS & USAGE SECTION

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


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

WARNINGS

WARNINGS SECTION

Do not use
if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have
kidney disease. Your doctor should determine if you need a different dose.

When using this product


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

If pregnant or breast-feeding
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.
  • 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




fexofenadine-180mg-10s-carton.jpgfexofenadine-180mg-10s-carton.jpg

62207-765-5162207-765-51

62207-765-8862207-765-88

62207-766-3562207-766-35

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130362207765510GTIN-13: 0362207765510
EAN-13: 0362207765510
GTIN-12: 362207765510
UPC-A: 362207765510
GTIN storage (14 digits): 00362207765510
62207-765-51.jpg
BarcodeEAN-130362207766517GTIN-13: 0362207766517
EAN-13: 0362207766517
GTIN-12: 362207766517
UPC-A: 362207766517
GTIN storage (14 digits): 00362207766517
fexofenadine-180mg-10s-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#

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-08-05full-release2026-06-01 01:19:04

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 43.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2019-12-13 00:20 UTC2019-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1874a2ff9319b5…

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 Ltd3151bc6d-b40b-4200-a5cf-e57b6791d92a2026-06-15WarningsExact identifier
ndc (package): 62207-765-51
ndc (package): 62207-765-60
ndc (package): 62207-765-49
ndc (package): 62207-766-35
ndc (package): 62207-766-51
ndc (package): 62207-765-88
ndc (package): 62207-766-49
ndc (package): 62207-766-58
ndc (product): 62207-765
ndc (product): 62207-766
ndc11 (package): 62207076588
ndc11 (package): 62207076635
ndc11 (package): 62207076551
ndc11 (package): 62207076658
ndc11 (package): 62207076560
ndc11 (package): 62207076549
ndc11 (package): 62207076651
ndc11 (package): 62207076649
spl id: 5447dc7c-b363-56c6-e063-6294a90a729d
spl set id: 3151bc6d-b40b-4200-a5cf-e57b6791d92a

Reported adverse events (FAERS/openFDA)#

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