Home DailyMed 767b082e-915d-482f-8c6b-22b6e23bca19 Fexofenadine Hydrochloride Tablets USP, 180 mg Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer A-S Medication Solutions
Effective date 2023-12-27
Label type Human OTC Drug Label
Version 1
Source full-release
Hydrated at 2026-06-01 00:05:48 Label at a glance# Product Fexofenadine HCL
Active ingredient FEXOFENADINE HYDROCHLORIDE
Label structure 13 sections
Dosage and administration 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
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 997420 fexofenadine HCl 180 MG 24 HR Oral Tablet PSN 1 997420 fexofenadine hydrochloride 180 MG Oral Tablet SCD 1 997420 fexofenadine HCl 180 MG 24 HR Oral Tablet SY 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6965-0 Fexofenadine HCL 1 in 1 CARTON TABLET 1 1 50090-6965-0 Fexofenadine HCL 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6965 FEXOFENADINE HCL TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20231228_767b082e-915d-482f-8c6b-22b6e23bca19.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 16 matching rows.
Fexofenadine HCL FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) LIGHT MINERAL OIL MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 STARCH, CORN FERRIC OXIDE RED FERRIC OXIDE YELLOW SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 14 matching rows.
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 45 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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.
Product history page 1 of 4 · 135 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 c2088c7a36db…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…
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