Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 96952314-fd4c-455f-b55e-645c19d6e366

Route

ORAL

Published

Effective Date 2018-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Butylated Hydroxytoluene Gelatin Glycerin Polyethylene Glycol 400 Sodium Hydroxide

Identifiers & Packaging

Pill Appearance

Shape: oval Color: yellow Size: 14 mm Score: 1

Marketing Status

ANDA Active Since 2014-12-16

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 mg

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

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

Directions

Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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

Manufactured For

A&Z Pharmaceutical, Inc.

Hauppauge, NY 11788

Other Information

store between 20°C to 25°C (68°F to 77°F )
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink

Questions Or Comments?

Call 1-888-952-0050

Monday through Friday 9AM – 5PM EST

Stop Use and Ask Doctor

if an allergic reaction to this product occurs. Seek medical help right away.

When Using This Product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when drivinga motor vehicle or operating machinery

If Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each Softgel)

Cetirizine HCl 10 mg

Package/label Principal Display Panel

Cetirizine HCl 10mg Softgels

Ask Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

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

Antihistamine

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

Directions

Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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

Manufactured For (Manufactured for)

A&Z Pharmaceutical, Inc.

Hauppauge, NY 11788

Other Information (Other information)

store between 20°C to 25°C (68°F to 77°F )
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink

Questions Or Comments? (Questions or Comments?)

Call 1-888-952-0050

Monday through Friday 9AM – 5PM EST

Stop Use and Ask Doctor (Stop use and ask doctor)

if an allergic reaction to this product occurs. Seek medical help right away.

When Using This Product (When using this product)

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when drivinga motor vehicle or operating machinery

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Cetirizine HCl 10 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Cetirizine HCl 10mg Softgels

Ask Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "Antihistamine", "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", "Directions": "Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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", "Manufactured for": "A&Z Pharmaceutical, Inc. Hauppauge, NY 11788", "Other information": "store between 20°C to 25°C (68°F to 77°F ) do not use if imprinted safety seal under cap is broken or missing ", "Inactive Ingredients": "butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink", "Questions or Comments?": "Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST", "Stop use and ask doctor": "if an allergic reaction to this product occurs. Seek medical help right away.", "When using this product": "drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery", "If pregnant or breast-feeding": "If pregnant or breast-feeding, ask a health professional before use.", "Keep Out of Reach of Children": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "Active ingredient (in each softgel)": "Cetirizine HCl 10 mg", "Package/Label Principal Display Panel": "Cetirizine HCl 10mg Softgels", "Ask doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:43.380332 · Updated: 2026-03-14T22:55:23.037919