Cetrizine Hcl Tablet 10 Mg

SPL v3

SPL

SPL Set ID 66e7c776-4ae3-43e0-ac3e-c0bf3ad98795

Route

ORAL

Published

Effective Date 2019-04-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Lactose Monohydrate Microcrystalline Cellulose Starch, Corn Magnesium Stearate Hypromellose, Unspecified Polydextrose Polyethylene Glycol 3350 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 10MG;APO Shape: rectangle Color: white Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2007-12-27

Description

Drug Facts

Purpose

Antihistamine

How Supplied

Product: 50090-3188 NDC: 50090-3188-0 14 TABLET, FILM COATED in a BOTTLE NDC: 50090-3188-1 30 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3188-3 90 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3188-2 100 TABLET, FILM COATED in a BOTTLE, PLASTIC

Medication Information

Warnings and Precautions

If pregnant or breast-feeding:

if breast-feeding; not recommended
if pregnant; ask a health professional before use

Purpose

Antihistamine

How Supplied

Product: 50090-3188

NDC: 50090-3188-0 14 TABLET, FILM COATED in a BOTTLE

NDC: 50090-3188-1 30 TABLET, FILM COATED in a BOTTLE, PLASTIC

NDC: 50090-3188-3 90 TABLET, FILM COATED in a BOTTLE, PLASTIC

NDC: 50090-3188-2 100 TABLET, FILM COATED in a BOTTLE, PLASTIC

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

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

Section 50570-1

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.

Warnings

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

Other Information

store between 20° and 25°C (68° - 77°F)
USP Dissolution Test 3

Inactive Ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions Or Comments?

call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:	Manufactured for:
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	33326

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

Cetirizine Hydrochloride

Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

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

Warnings and Precautions (34071-1)

If pregnant or breast-feeding:

if breast-feeding; not recommended
if pregnant; ask a health professional before use

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Purpose

Antihistamine

Warnings

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

How Supplied (HOW SUPPLIED)

Product: 50090-3188

NDC: 50090-3188-0 14 TABLET, FILM COATED in a BOTTLE

NDC: 50090-3188-1 30 TABLET, FILM COATED in a BOTTLE, PLASTIC

NDC: 50090-3188-3 90 TABLET, FILM COATED in a BOTTLE, PLASTIC

NDC: 50090-3188-2 100 TABLET, FILM COATED in a BOTTLE, PLASTIC

Other Information (Other information)

store between 20° and 25°C (68° - 77°F)
USP Dissolution Test 3

Inactive Ingredients (Inactive ingredients)

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions Or Comments? (Questions or comments?)

call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:	Manufactured for:
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	33326

When Using This Product (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

Cetirizine Hydrochloride

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine HCl, USP 10 mg

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYDEXTROSE", "unii": "VH2XOU12IE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "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", "34071-1": "If pregnant or breast-feeding: if breast-feeding; not recommended if pregnant; ask a health professional before use", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "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.", "Purpose": "Antihistamine", "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", "HOW SUPPLIED": "Product: 50090-3188 NDC: 50090-3188-0 14 TABLET, FILM COATED in a BOTTLE NDC: 50090-3188-1 30 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3188-3 90 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3188-2 100 TABLET, FILM COATED in a BOTTLE, PLASTIC", "Other information": "store between 20° and 25°C (68° - 77°F) USP Dissolution Test 3", "Inactive ingredients": "Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.", "Questions or comments?": "call 1-800-706-5575 , weekdays, 8:30am - 5:00pm Eastern Standard Time Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326", "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", "Active ingredient (in each tablet)": "Cetirizine HCl, USP 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:47.896175 · Updated: 2026-03-14T22:55:31.631898