Indications and uses
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
Fexofenadine Hydrochloride
- Manufacturer
- Granules USA, Inc
- Effective date
- 2020-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:44:35
Label at a glance#
ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 sections
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
(in each film-coated tablet)
Fexofenadine HCl USP 180 mg
Purpose
Antihistamine
Uses
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 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 and breast-feeding,
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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
■ store between 20°and 25°C (68°and 77°F)
■ protect from excessive moisture
■ each tablet contains: sodium 8.2 mg
■ this product meets the requirements of USP Dissolution Test 2
■ Tamper Evident: Do not use if imprinted inner safety seal is torn or missing
Inactive ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide and yellow iron oxide.
Questions or comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Fexofenadine Hydrochloride
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- ANHYDROUS LACTOSE
- STARCH, CORN
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- FERRIC OXIDE RED
- STEARIC ACID
- FERRIC OXIDE YELLOW
- FEXOFENADINE
- SILICON DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69848-002 | 69848-002-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 |
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.
| 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 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0eb1d92f-f1fa-0b51-e063-6394a90a91e2 | 68065bdb-0e39-21b2-e053-2991aa0a571b | 2024-01-11 | Warnings | 68065bdb-0e39-21b2-e053-2991aa0a571b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.