Cetirizine Hydrochloride Tablets

SPL v9

SPL

SPL Set ID 214936a2-adc4-422a-a8fe-4c3ce9e01f36

Route

ORAL

Published

Effective Date 2024-07-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Povidone Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: IP;45 Shape: oval Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2010-01-21

Description

Drug Facts

Indications and Usage

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

Medication Information

Indications and Usage

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

Description

Drug Facts

Section 42229-5

Drug Facts

Stop Use

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

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 Doctor

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

Directions

Adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65 years and over	1 tablet (5 mg) once daily; 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

Otc Questions

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

Active Ingredient

(in each tablet)

Cetirizine HCl, USP 5 mg

Other Information

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Ask Doctor/pharmacist

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

Pregnancy Or Breast Feeding

If pregnant or breast-feeding :

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

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)

Package Label.principal Display Panel

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Purpose (PURPOSE)

Antihistamine

Stop Use (STOP USE)

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

Warnings (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 Doctor (ASK DOCTOR)

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

Directions (DIRECTIONS)

Adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65 years and over	1 tablet (5 mg) once daily; 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

Otc Questions (OTC - QUESTIONS)

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

Active Ingredient (ACTIVE INGREDIENT)

(in each tablet)

Cetirizine HCl, USP 5 mg

Other Information (OTHER INFORMATION)

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

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

Indications and Usage (INDICATIONS AND USAGE)

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

Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

If pregnant or breast-feeding :

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

Keep Out of Reach of Children (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)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "Drug Facts", "PURPOSE": "Antihistamine", "STOP USE": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "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 DOCTOR": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "DIRECTIONS": "Adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. Adults 65 years and over 1 tablet (5 mg) once daily; 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", "OTC - QUESTIONS": "Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST.", "ACTIVE INGREDIENT": "(in each tablet) Cetirizine HCl, USP 5 mg", "OTHER INFORMATION": "Other information • store between 20° to 25°C (68° to 77°F)", "INACTIVE INGREDIENTS": "Inactive ingredients lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.", "ASK DOCTOR/PHARMACIST": "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", "INDICATIONS AND USAGE": "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", "PREGNANCY OR BREAST FEEDING": "If pregnant or breast-feeding : • if breast-feeding: not recommended • if pregnant: ask a health professional before use.", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:23.427561 · Updated: 2026-03-14T23:03:27.182760