Home DailyMed abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS 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 Apotheca Inc.
Effective date 2010-04-07
Label type HUMAN OTC DRUG LABEL
Version 2
Source full-release
Hydrated at 2026-05-31 22:24:11 Label at a glance# Product CETIRIZINE HYDROCHLORIDE
Active ingredient CETIRIZINE HYDROCHLORIDE
Label structure 13 sections
Dosage and administration Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1014678 cetirizine HCl 10 MG Oral Tablet PSN 2 1014678 cetirizine hydrochloride 10 MG Oral Tablet SCD 2 1014678 cetirizine HCl 10 MG Oral Tablet SY 2
DailyMed Pharmacologic Classes# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-987-00 CETIRIZINE HYDROCHLORIDE 10 in 1 BOTTLE, PLASTIC TABLET 10 2 12634-987-01 CETIRIZINE HYDROCHLORIDE 100 in 1 BOTTLE, PLASTIC TABLET 100 2 12634-987-50 CETIRIZINE HYDROCHLORIDE 50 in 1 BOTTLE, PLASTIC TABLET 50 2 12634-987-71 CETIRIZINE HYDROCHLORIDE 30 in 1 BOTTLE, PLASTIC TABLET 30 2 12634-987-80 CETIRIZINE HYDROCHLORIDE 20 in 1 BOTTLE, PLASTIC TABLET 20 2 12634-987-96 CETIRIZINE HYDROCHLORIDE 6 in 1 BOTTLE, PLASTIC TABLET 6 2 12634-987-97 CETIRIZINE HYDROCHLORIDE 7 in 1 BOTTLE, PLASTIC TABLET 7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-987 CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] 2 Legacy NDC, 7 package rows 20100408_abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA 2 CETIRIZINE ACTIVE MOIETY YO7261ME24 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP 2
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 6 matching rows.
CETIRIZINE HYDROCHLORIDE CETIRIZINE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE HYPROMELLOSE TITANIUM DIOXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 5 matching rows.
Inactive ingredient matches# 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.
Inactive ingredient links page 1 of 1 · 4 matching rows.
DailyMed ingredient, IID ingredient, UNII table DailyMed ingredient IID ingredient UNII Dosage form / route Potency Maximum daily exposure Match HYPROMELLOSE HYPROMELLOSE 3NXW29V3WO TABLET, FILM COATED / ORAL 582 mg Exact identifier — unii+route+dosage form MAGNESIUM STEARATE MAGNESIUM STEARATE 70097M6I30 TABLET, FILM COATED / ORAL 96 mg Exact identifier — unii+route+dosage form CELLULOSE, MICROCRYSTALLINE MICROCRYSTALLINE CELLULOSE OP1R32D61U TABLET, FILM COATED / ORAL 992 mg Exact identifier — unii+route+dosage form TITANIUM DIOXIDE TITANIUM DIOXIDE 15FIX9V2JP TABLET, FILM COATED / ORAL 36 mg Exact identifier — unii+route+dosage form
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 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…
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Matched openFDA labels page 1 of 1 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.