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Curist Allergy Relief

Levocetirizine dihydrochloride 5 mg · Tablet

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
Curist Allergy Relief
Generic name
Levocetirizine dihydrochloride 5 mg
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Little Pharma, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Fexofenadine Hydrochloride 180 mg/1 997501 View
Levocetirizine Dihydrochloride 5 mg/1 855172 View
Loratadine 10 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
13

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
213513
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 29, 2020
Sponsor
HETERO LABS LTD III
Products on application
1
Submissions recorded
1
Products approved under application 213513.
Product Trade name Form Strength Ingredient Status TE Flags
213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET LEVOCETIRIZINE DIHYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213513.
Type No. Action Status Date Review
Original application 1 Approved April 29, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260305). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260305 HUMAN OTC DRUG · 20250615 HUMAN OTC DRUG · 20241115

Indications and Usage

openFDA Drug Labeling

Uses 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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults 65 years and older ask a doctor adults and children 12-64 years take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1⁄2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years take 1⁄2 tablet (2.5 mg) once daily in the evening do not take more than 1⁄2 tablet (2.5 mg) in 24 hours children under 6 years do not use consumers with kidney disease do not use

Warnings

openFDA Drug Labeling

Warnings Do not use if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder. 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 you have trouble urinating or emptying your bladder 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 (1-800-222-1222) right away.

Do Not Use

openFDA Drug Labeling

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

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 you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 180 mg

Adverse event reports

Source: openFDA FAERS
114,194
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: LORATADINE. 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.

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
72559-021-05 72559-021 Little Pharma, Inc. 1 BOTTLE in 1 CARTON (72559-021-05) / 90 TABLET in 1 BOTTLE January 24, 2023
72559-021-15 72559-021 Little Pharma, Inc. 1 BOTTLE in 1 CARTON (72559-021-15) / 90 TABLET in 1 BOTTLE January 24, 2023
72559-021-48 72559-021 Little Pharma, Inc. 365 TABLET in 1 BOTTLE (72559-021-48) April 4, 2025
72559-021-56 72559-021 Little Pharma, Inc. 180 TABLET in 1 BOTTLE (72559-021-56) February 27, 2024
72559-027-22 72559-027 Little Pharma, Inc. 200 TABLET in 1 BOTTLE (72559-027-22) March 30, 2023
72559-027-23 72559-027 Little Pharma, Inc. 300 TABLET in 1 BOTTLE (72559-027-23) January 31, 2024
72559-027-46 72559-027 Little Pharma, Inc. 30 TABLET in 1 BOTTLE (72559-027-46) February 22, 2024
72559-033-47 72559-033 Little Pharma, Inc. 90 TABLET in 1 BOTTLE (72559-033-47) December 12, 2023
72559-033-48 72559-033 Little Pharma, Inc. 365 TABLET in 1 BOTTLE (72559-033-48) December 12, 2023
72559-033-63 72559-033 Little Pharma, Inc. 500 TABLET in 1 BOTTLE (72559-033-63) June 30, 2025
72559-021 72559-021 Little Pharma, Inc. — January 24, 2023
72559-027 72559-027 Little Pharma, Inc. — March 30, 2023
72559-033 72559-033 Little Pharma, Inc. — December 12, 2023

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

Generated September 25, 2026 · 10 sections on this page.