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CareOne Allergy Relief

Cetirizine Hydrochloride · Tablet, Film Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
CareOne Allergy Relief
Generic name
Cetirizine Hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
American Sales Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
9
Data completeness
77% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cetirizine Hydrochloride 10 mg/1 1014678 View
Fexofenadine Hydrochloride 180 mg/1 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
078336
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 27, 2007
Sponsor
PERRIGO R AND D
Products on application
4
Submissions recorded
2
Products approved under application 078336.
Product Trade name Form Strength Ingredient Status TE Flags
078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
078336-003 CETIRIZINE HYDROCHLORIDE HIVES TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
078336-004 CETIRIZINE HYDROCHLORIDE HIVES TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 078336.
Type No. Action Status Date Review
Supplement 10 Labeling Approved May 27, 2010 —
Original application 1 Approved December 27, 2007 —

Review documents

  • 0 · Original application · January 9, 2008
  • 0 · Original application · January 8, 2008

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250825). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250825 HUMAN OTC DRUG · 20210712

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions 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. A 5 mg product may be appropriate for less severe symptoms. 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

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Fexofenadine HCl 180 mg

Adverse event reports

Source: openFDA FAERS
166,303
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CETIRIZINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II July 19, 2023 L. Perrigo Company Failed Impurities/Degradation Specifications Terminated
Class II January 12, 2022 Perrigo Company PLC Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
41520-229-22 41520-229 American Sales Company 15 BLISTER PACK in 1 CARTON (41520-229-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK October 14, 2016
41520-229-39 41520-229 American Sales Company 1 BOTTLE in 1 CARTON (41520-229-39) / 30 TABLET, FILM COATED in 1 BOTTLE October 14, 2016
41520-229-95 41520-229 American Sales Company 1 BOTTLE in 1 CARTON (41520-229-95) / 45 TABLET, FILM COATED in 1 BOTTLE October 14, 2016
41520-781-06 41520-781 American Sales Company 1 BOTTLE in 1 CARTON (41520-781-06) / 70 TABLET, FILM COATED in 1 BOTTLE September 29, 2016
41520-781-39 41520-781 American Sales Company 1 BOTTLE in 1 CARTON (41520-781-39) / 30 TABLET, FILM COATED in 1 BOTTLE September 29, 2016
41520-781-66 41520-781 American Sales Company 14 BLISTER PACK in 1 CARTON (41520-781-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK September 29, 2016
41520-781-76 41520-781 American Sales Company 1 BOTTLE in 1 CARTON (41520-781-76) / 120 TABLET, FILM COATED in 1 BOTTLE April 12, 2019
72476-847-22 72476-847 Retail Business Services, LLC 15 BLISTER PACK in 1 CARTON (72476-847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK December 26, 2021
72476-847-95 72476-847 Retail Business Services, LLC 1 BOTTLE in 1 CARTON (72476-847-95) / 45 TABLET, FILM COATED in 1 BOTTLE December 29, 2021
41520-229 41520-229 American Sales Company — October 14, 2016
41520-781 41520-781 American Sales Company — September 29, 2016
72476-847 72476-847 Retail Business Services, LLC — December 26, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.