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Cetirizine

Also sold as Cetirizine HCl

From 1 official FDA drug label · RxNorm 1014676, 1014678

This comes from U.S. FDA labels. Brand names, strengths and advice can differ in your country; check with a local health professional. Set your country.

What it is used for

These are the uses the FDA has approved for this label. Using it for anything else is “off-label”: ask your prescriber why.

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

How to take it

Directions Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 10 mg 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

Serious warnings and precautions

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine Ask a doctor before useif 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 • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. 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)

Keep out of reach of children

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)

Forms and strengths available

10 MG · Disintegrating Oral Tablet5 MG · Chewable Tablet1 MG/ML · Oral Solution10 MG · Chewable Tablet10 MG · Oral Capsule5 MG · Oral Tablet10 MG · Oral Tablet2.4 MG/ML · Ophthalmic Solution2.5 MG · Chewable Tablet

From RxNorm. Which forms and strengths are actually stocked varies by pharmacy and country.

Reactions people have reported

pruritus 4insomnia 3weight increased 3drug ineffective 3chronic spontaneous urticaria 2constipation 2condition aggravated 2abdominal pain 2off label use 2angioedema 2

These are counts from 9 voluntary reports to the FDA. They show what has been reported — they are not how common a side effect is, and they do not prove the medicine caused it.

Recalls

Class I · Jul 29, 2026
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class III · Oct 29, 2025
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Reason: Tablet/Capsules Imprinted with Wrong ID
Class III · Oct 29, 2025
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Reason: Tablet/Capsules Imprinted with Wrong ID
Class II · Apr 16, 2025
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Reason: CGMP Deviations
Class III · Nov 17, 2021
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Reason: Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Class II · Nov 21, 2018
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
Reason: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class III · Dec 30, 2015
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026)
Reason: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Oct 24, 2012
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Reason: Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

Research & studies

Recent higher-quality studies about Cetirizine, from PubMed. We link to the source — titles only. This is not medical advice.

ReviewCase Report: dupilumab for severe pruritus in pediatric recessive dystrophic epidermolysis bullosa-a longitudinal clinical assessment and literature review.Frontiers in immunology · 2026ReviewOral Second-Generation H1-Antihistamine Regimens for Allergic Rhinitis: Systematic Review and Network Meta-Analysis of Effects and Estimability.Journal of clinical medicine · 2026 Sep 15Systematic ReviewSecond-generation H1 antihistamines for the treatment of chronic urticaria: a network meta-analysis.Frontiers in medicine · 2026Systematic ReviewAntihistamines for atopic dermatitis (eczema): systematic review and network meta-analysis of randomised trials.BMJ (Clinical research ed.) · 2026 Jul 29Systematic ReviewBeyond Minoxidil: Off-Label Therapies for Male Androgenetic Alopecia-A Systematic Review with Network Meta-Analyses.Medicina (Kaunas, Lithuania) · 2026 Jul 3Systematic ReviewThe impact of antihistamine use on allergic reactions in pregnancy.Drug metabolism and personalized therapy · 2026 Sep 1

Similar medicines

Cetirizine belongs to the Piperazine derivatives class. Other medicines in it:

meclizine

Questions to ask your doctor or pharmacist

Why you can trust this

Everything above comes from official FDA drug labels (openFDA), not written by us. Here are the exact labels used.

This information explains the official label. It cannot tell you whether this medicine is right or safe for you personally — only a qualified health professional who knows your history can do that. Do not start, stop, or change a medicine based on this page alone.