Allergy Relief

SPL v5

SPL

SPL Set ID b079e2e5-8e4b-4419-bfe5-2315c861a5d1

Route

ORAL

Published

Effective Date 2022-05-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Lactose Monohydrate Povidone Starch, Corn Magnesium Stearate Titanium Dioxide Hypromelloses Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: CTN10 Shape: square Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2022-05-27

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 • itchy, watery eyes • sneezing • itching of the nose or throat

Section 50565-1

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)

Section 50566-9

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

Section 50567-7

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

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.

Section 53414-9

If pregnant or breast-feeding, • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

Directions

adults & children 6 years & 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 & over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Drug Facts

Other Information

• store between 20–25°C (68–77°F)

Inactive Ingredients

Lactose, povidone, maize starch, magnesium stearate, purified water, titanium dioxide, hypromellose, macrogol

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

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.(1-800-222-1222)

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 50567-7 (50567-7)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

Purpose

Antihistamine

Directions

adults & children 6 years & 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 & over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Drug Facts

Other Information (Other information)

• store between 20–25°C (68–77°F)

Inactive Ingredients (Inactive ingredients)

Lactose, povidone, maize starch, magnesium stearate, purified water, titanium dioxide, hypromellose, macrogol

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Cetirizine HCl 10 mg

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "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": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat", "50565-1": "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)", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "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", "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.", "53414-9": "If pregnant or breast-feeding, • if breast-feeding: not recommended • if pregnant: ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "adults & children 6 years & 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 & 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 20–25°C (68–77°F)", "Inactive ingredients": "Lactose, povidone, maize starch, magnesium stearate, purified water, titanium dioxide, hypromellose, macrogol", "Questions or comments?": "1-888-333-9792", "Active Ingredient (in each tablet)": "Cetirizine HCl 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.710412 · Updated: 2026-03-14T23:06:13.532900