FDA.reportPublic FDA data

Fexofenadine HCl Tablets USP

Manufacturer
BluePoint Laboratories | DR. REDDY'S LABORATORIES LIMITED | Dr. Reddy's Laboratories Limited (FTO III)
Effective date
2026-07-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-18 05:10:14

Label at a glance#

ProductFexofenadine hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure12 sections

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(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 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, 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

OTC - WHEN USING 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 doctor if

OTC - STOP USE 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 (1-800-222-1222)..

Directions

DOSAGE & ADMINISTRATION SECTION

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 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 printed foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine bottle labelFexofenadine bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine CartonFexofenadine CartonFexofenadine HCL Tablets, 60 mg Carton:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton 180 mgCarton 180 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 180mgLabel 180mgFexofenadine Hcl Tablets USP 180 mg 30 ct bottle labelFexofenadine Hcl Tablets USP 180 mg 30 ct bottle label

Fexofenadine bottle label 180 mg 30 ctFexofenadine bottle label 180 mg 30 ct

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-439-00EA - Each68001-43962c873d1-5a8e-4c1f-85bb-9bb11fcbabed12020-09-14
68001-440-00EA - Each68001-440a9ec692b-3f00-4787-84b4-33be23d348cb12020-09-14
68001-440-04EA - Each68001-4409705ddeb-f38b-4f76-9b50-50440fefda7012020-09-14

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
68001-43968001-439-00
68001-44068001-440-00, 68001-440-04

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22021-03-12full-release2026-05-31 23:39:01

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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076502-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11
A076502-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11
A076502-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11
A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12
A076502-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12

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 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-08-18 06:07:402026-07A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-126a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076502-001AB18072bd15b7f6…

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 HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsExact identifier
ndc (package): 68001-440-00
ndc (package): 68001-439-00
ndc (package): 68001-440-04
ndc (product): 68001-440
ndc (product): 68001-439
ndc11 (package): 68001043900
ndc11 (package): 68001044004
ndc11 (package): 68001044000
spl id: 56816fcb-3ed9-be09-e063-6294a90a18ae
spl set id: a86aebd0-937e-5d73-e053-2995a90a656a

Reported adverse events (FAERS/openFDA)#

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