Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Fexofenadine Hydrochloride Tablets USP
- Manufacturer
- Aurohealth LLC | APL HEALTHCARE LIMITED
- Effective date
- 2026-08-06
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-08-13 01:01:11
Label at a glance#
ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure16 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Fexofenadine HCl USP, 30 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or 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 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 |
Other information
- safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture and light
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 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg (30 Tablets Container Label)
AUROHEALTH
NDC 58602-876-09
NON-DROWSY
Children's
Fexofenadine Hydrochloride
Tablets USP, 30 mg
Antihistamine
Allergy
Ages 6 Years and Older
INDOOR/OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
12 Hour
30 TABLETS
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg (30 Tablets Container Carton Label)
AUROHEALTH
NDC 58602-876-09
*Compare to Children's Allegra®
Allergy active ingredient
NON-DROWSY
Children's
Fexofenadine
Hydrochloride
Tablets USP, 30 mg
A
ntihistamine
Allergy
12 Hour
Ages 6 Years and Older
INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
DO NOT USE IF FOIL SEAL
IS TORN OR MISSING
30 TABLETS
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg Blister Carton (1 x 5 Unit-dose)
AUROHEALTH
NDC 58602-876-60
*Compare to Children’s Allegra®
Allergy active ingredient
NON-DROWSY
Children's
Fexofenadine Hydrochloride
Tablets USP, 30 mg
Antihistamine
Allergy
12 Hour
Ages 6 Years and Older
INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
DO NOT USE IF BLISTER UNITS
ARE BROKEN OR TORN
5 TABLETS
Products#
Every source-derived product name is available through these pages.
- Fexofenadine Hydrochloride
- FEXOFENADINE
- ANHYDROUS LACTOSE
- SILICON DIOXIDE
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE 2910 (6 MPA.S)
- LACTOSE MONOHYDRATE
- POLYETHYLENE GLYCOL 400
- FERRIC OXIDE RED
- STEARIC ACID
- TITANIUM DIOXIDE
- FERRIC OXIDE YELLOW
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-876 | 58602-876-09, 58602-876-40, 58602-876-60 |
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 |
|---|---|---|---|---|---|---|---|
| A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2014-11-19 | ||
| A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2014-11-19 | ||
| A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2014-11-19 |
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 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 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 |
|---|---|---|---|---|---|---|
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Aurohealth LLC | eb8e67dc-e2df-4c35-bfd7-12af67e1354a | 2026-08-06 | Warnings | 58602-876-60 58602-876-09 58602-876-40 58602-876 58602087609 58602087660 58602087640 eb8e67dc-e2df-4c35-bfd7-12af67e1354a eb8e67dc-e2df-4c35-bfd7-12af67e1354a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.