Allegra Allergy

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:45

Label at a glance#

ProductAllegra Allergy
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

 adults and children 12 years of age and over  take one 180mg 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 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 desease.  Your doctor should determine ifyou 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 a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years of age and over take one 180mg 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

  • ​safety sealed: do not use if individual blister is open or torn
  • ​store between 20 ​o and 25 ​o C (68 ​o​ and 77 ​o​F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-633-1610 or www.allegra.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allegra 1ctAllegra 1ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997422Allegra 180 MG Oral TabletPSN8
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD8
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8
997422Allegra 180 MG Oral TabletSY8
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8

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
67751-033-01Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
67751-033-02Allegra Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
67751-033-02Allegra Allergy1 in 1 CARTONTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4120-0EA - Each41167-4120a319bd76-8ddf-44b6-b1cc-2ba117185f6d12012-07-24
41167-4120-2EA - Each41167-412056bcf949-12a0-42c0-b487-9d700456915b12012-07-24
41167-4120-3EA - Each41167-41203a70589e-d283-4343-a1e4-566c12814ee612012-07-24
41167-4120-4EA - Each41167-4120496e2b39-5506-46c2-a111-be6de6cd017612012-07-24
41167-4120-5EA - Each41167-4120dca89411-559c-49cc-903c-a7966c80475e12012-07-24
41167-4120-6EA - Each41167-41203244b127-7096-4dff-9e71-8410ec8d785412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZU1
FEXOFENADINEACTIVE MOIETYE6582LOH6V1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-03367751-033-01, 67751-033-02
41167-4120

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020872-005CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24
N020872-006CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALRLD2011-01-24
N020872-007ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-008ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALRLD2011-01-24
N020872-009ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24
N020872-010ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALRLD, RS2011-01-24

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2484e616aacf4f…
2026-08-18 06:07:402026-07N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-009ALLEGRA HIVES180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020872-010ALLEGRA ALLERGY180MGTABLET / ORALRLD, RS2011-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-005CHILDREN'S ALLEGRA ALLERGY30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-006CHILDREN'S ALLEGRA HIVES30MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-007ALLEGRA ALLERGY60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020872-008ALLEGRA HIVES60MGTABLET / ORALRLD2011-01-24b8a1b40f171c…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra AllergyFEXOFENADINE HYDROCHLORIDENavajo Manufacturing Company Inc.e8a00fa1-79af-4ce6-885f-0ce12c5da8362026-04-22WarningsExact identifier
ndc (package): 67751-033-01
ndc (package): 67751-033-02
ndc (product): 67751-033
ndc11 (package): 67751003301
ndc11 (package): 67751003302
spl id: 50105c7e-4025-1a55-e063-6394a90a88b4
spl set id: e8a00fa1-79af-4ce6-885f-0ce12c5da836
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd1732026-04-14WarningsExact identifier
ndc (product): 41167-4120

Reported adverse events (FAERS/openFDA)#

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