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
temporarily relieves these symptoms due to hay fever or upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
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
Fexofenadine HCl 180 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
if you have ever had an allergic reaction to this product or any of its ingredients.
kidney desease. Your doctor should determine ifyou need a different dose.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| 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 |
colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide
Call toll-free 1-800-633-1610 or
www.allegra.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 997422 | Allegra 180 MG Oral Tablet | PSN | 8 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 8 |
| 997422 | fexofenadine hydrochloride 180 MG Oral Tablet [Allegra] | SBD | 8 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 8 |
| 997422 | Allegra 180 MG Oral Tablet | SY | 8 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-033-01 | Allegra Allergy | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 8 | |
| 67751-033-02 | Allegra Allergy | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 8 | |
| 67751-033-02 | Allegra Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41167-4120-0 | EA - Each | 41167-4120 | a319bd76-8ddf-44b6-b1cc-2ba117185f6d | 1 | 2012-07-24 |
| 41167-4120-2 | EA - Each | 41167-4120 | 56bcf949-12a0-42c0-b487-9d700456915b | 1 | 2012-07-24 |
| 41167-4120-3 | EA - Each | 41167-4120 | 3a70589e-d283-4343-a1e4-566c12814ee6 | 1 | 2012-07-24 |
| 41167-4120-4 | EA - Each | 41167-4120 | 496e2b39-5506-46c2-a111-be6de6cd0176 | 1 | 2012-07-24 |
| 41167-4120-5 | EA - Each | 41167-4120 | dca89411-559c-49cc-903c-a7966c80475e | 1 | 2012-07-24 |
| 41167-4120-6 | EA - Each | 41167-4120 | 3244b127-7096-4dff-9e71-8410ec8d7854 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | 1 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-033 | 67751-033-01, 67751-033-02 |
| 41167-4120 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FEXOFENADINE HYDROCHLORIDE | 2S068B75ZU | ACTIB |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020872-005 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-006 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-007 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-008 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-009 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | |
| N020872-010 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | e8a00fa1-79af-4ce6-885f-0ce12c5da836 | 2026-04-22 | Warnings | 67751-033-01 67751-033-02 67751-033 67751003301 67751003302 50105c7e-4025-1a55-e063-6394a90a88b4 e8a00fa1-79af-4ce6-885f-0ce12c5da836 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 2026-04-14 | Warnings | 41167-4120 |
Adverse event summaries are temporarily unavailable. Other product information remains available.