Fexofenadine
- Manufacturer
- DirectRx
- Effective date
- 2023-06-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:29:50
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Fexofenadine hydrochloride USP, 180 mg
OTC - PURPOSE SECTION
Antihistamine
OTC - WHEN USING 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
OTC - DO NOT USE SECTION
if you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR/PHARMACIST SECTION
you have kidney disease. Your doctor should determine if you need a different dose.
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)
OTC - STOP USE SECTION
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
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.
OTC - QUESTIONS SECTION
call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-305-30 | EA - Each | 72189-305 | 40dd8176-a796-4ea7-bf35-b73c853af2f4 | 1 | 2022-01-06 |
| 69230-300-01 | EA - Each | 69230-300 | ed263974-8cdb-44b0-8188-4e93e23e1f90 | 1 | 2019-03-12 |
| 69230-300-05 | EA - Each | 69230-300 | 7f850864-2586-4f99-bee1-a64ff744fc33 | 1 | 2019-04-11 |
| 69230-300-30 | EA - Each | 69230-300 | 752dfd0f-5625-4f3f-bd24-f82e34ca4850 | 1 | 2019-06-19 |
Products#
Every source-derived product name is available through these pages.
- Fexofenadine
- MAGNESIUM STEARATE
- FERRIC OXIDE RED
- FEXOFENADINE HYDROCHLORIDE
- HYPROMELLOSE 2910 (6 MPA.S)
- LIGHT MINERAL OIL
- STARCH, CORN
- TALC
- FERRIC OXIDE YELLOW
- TITANIUM DIOXIDE
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POLYETHYLENE GLYCOL 6000
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-305 | 72189-305-30 |
| 69230-300 |
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 |
|---|---|---|---|---|---|---|---|
| A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2016-08-19 |
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.
| 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 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| 074b53d0-d9db-8d24-e063-6294a90a9fda | d35a5ce4-cd83-5b1f-e053-2995a90a24db | 2023-10-09 | d35a5ce4-cd83-5b1f-e053-2995a90a24db | |||
| Fexofenadine HCL | FEXOFENADINE HCL | Camber Consumer Care | e437655c-f1f3-4b58-89ba-bf22e416d311 | 2019-03-06 | Warnings | 69230-300 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
