FDA.reportPublic FDA data

Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg

Manufacturer
Hetero Labs Limited
Effective date
2016-09-08
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:03

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 sections

Dosage and administration

30 mg adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in        24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in              24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
Fexofenadine Hydrochloride 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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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

OTC - ASK DOCTOR SECTION

you have 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.

PREGNANCY/BREASTFEEDING

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

30 mg


adults and children 12 years of age and over
take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in        24 hours
children 6 to under 12 years of age
take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in              24 hours
children under 6 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor

60 mg


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
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

180 mg


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

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Tamper Evident: Do not use if printed foil seal under cap is missing
  • This unit-dose package is not child-resistant
  • store between 20º and 25ºC (68º and 77ºF) 
  • protect from excessive moisture

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

QUESTIONS?

SPL UNCLASSIFIED SECTION

Call 1-866-495-1995

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton


Fexofenadine30mg30scarton
Fexofenadine30mg30scarton




Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label


Fexofendine30mg30slabel
Fexofendine30mg30slabel





Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil


Fexofendine30mg10sfoil
Fexofendine30mg10sfoil




Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton



Fexofendine30mg10scarton
Fexofendine30mg10scarton


Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton


Fexofenadine60mg30scarton
Fexofenadine60mg30scarton






Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label


Fexofenadine60mg30slabel
Fexofenadine60mg30slabel



Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil


Fexofenadine60mg10sfoil
Fexofenadine60mg10sfoil



Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton


Fexofenadine60mg10scarton
Fexofenadine60mg10scarton



Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton


Fexofenadine180mg30scarton
Fexofenadine180mg30scarton


Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label


Fexofendine180mg30slabel
Fexofendine180mg30slabel


Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil


Fexofendine180mg10sfoil
Fexofendine180mg10sfoil


Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton


Fexofenadine180mg10scarton
Fexofenadine180mg10scarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2
997488fexofenadine HCl 30 MG Oral TabletPSN2
997501fexofenadine HCl 60 MG Oral TabletPSN2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2
997488fexofenadine hydrochloride 30 MG Oral TabletSCD2
997501fexofenadine hydrochloride 60 MG Oral TabletSCD2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68554-5061-02020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5061-12020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5061-22020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5061-52020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5061-62020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5062-02020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5062-12020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5062-22020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5062-52020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5062-62020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-02020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-12020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-22020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-52020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg
68554-5063-62020-01-31C16284748780-19d75b9d0-a4d4-f424-e053-dadaa90a57ceFexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68554-5061-0Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5061-0Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68554-5061-1Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5061-1Fexofenadine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
68554-5061-2Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5061-2Fexofenadine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
68554-5061-3Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5061-4Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5061-5Fexofenadine Hydrochloride10 in 1 CARTONTABLET, FILM COATED102
68554-5061-6Fexofenadine Hydrochloride22 in 1 CARTONTABLET, FILM COATED222
68554-5062-0Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5062-0Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68554-5062-1Fexofenadine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
68554-5062-1Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5062-2Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5062-2Fexofenadine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
68554-5062-3Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5062-4Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5062-5Fexofenadine Hydrochloride7 in 1 CARTONTABLET, FILM COATED72
68554-5062-6Fexofenadine Hydrochloride15 in 1 CARTONTABLET, FILM COATED152
68554-5063-0Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-0Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68554-5063-1Fexofenadine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
68554-5063-1Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-2Fexofenadine Hydrochloride1 in 1 CARTONTABLET, FILM COATED12
68554-5063-2Fexofenadine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
68554-5063-3Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5063-4Fexofenadine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
68554-5063-5Fexofenadine Hydrochloride7 in 1 CARTONTABLET, FILM COATED72
68554-5063-6Fexofenadine Hydrochloride15 in 1 CARTONTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68554-5061FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED]2Legacy NDC, 10 package rows20160909_412af925-12e9-405f-b3c3-d5c3d0b5d5c2.zip
68554-5062FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED]2Legacy NDC, 10 package rows20160909_412af925-12e9-405f-b3c3-d5c3d0b5d5c2.zip
68554-5063FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED]2Legacy NDC, 10 package rows20160909_412af925-12e9-405f-b3c3-d5c3d0b5d5c2.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68554-506168554-5061-0, 68554-5061-1, 68554-5061-2, 68554-5061-4, 68554-5061-5, 68554-5061-3, 68554-5061-6
68554-506268554-5062-0, 68554-5062-1, 68554-5062-2, 68554-5062-4, 68554-5062-5, 68554-5062-3, 68554-5062-6
68554-506368554-5063-0, 68554-5063-1, 68554-5063-2, 68554-5063-4, 68554-5063-5, 68554-5063-3, 68554-5063-6

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSES3NXW29V3WOIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
FERRIC OXIDE RED1K09F3G675IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSES3NXW29V3WOIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
FERRIC OXIDE RED1K09F3G675IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSES3NXW29V3WOIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
FERRIC OXIDE RED1K09F3G675IACT
TALC7SEV7J4R1UIACT

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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2016-08-19
A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2016-08-19
A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2016-08-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19301d65b070ca…

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
58c4b4d8-26e4-cfe0-e063-6294a90a94ed412af925-12e9-405f-b3c3-d5c3d0b5d5c22026-08-11WarningsExact identifier
spl set id: 412af925-12e9-405f-b3c3-d5c3d0b5d5c2

Reported adverse events (FAERS/openFDA)#

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