Cetirizine Hydrochloride Tablets Usp 10 Mg

Cetirizine Hydrochloride Tablets Usp 10 Mg
SPL v4
SPL
SPL Set ID f756d3b1-d2e4-3705-e053-6294a90aa380
Route
ORAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Titanium Dioxide Lactose Monohydrate Starch, Corn Povidone K30 Magnesium Stearate Hypromelloses Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: J;220 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2023-02-07
Description

Active ingredient (in each tablet) Cetirizine HCl 10 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

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

Description

Active ingredient (in each tablet) Cetirizine HCl 10 mg

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 ifan 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 aretaking tranquilizers or sedatives.

Section 50569-3

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

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients, or to an antihistamine containing hydroxyzine.

Section 51727-6

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding:

• if breast-feeding: Not recommended

• if pregnant: Ask a health professional before use

Section 55105-1

Purpose

Antihistamine



Section 55106-9

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Section 60561-8

Other information

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

Principal Display Panel

NDC: 51655-842-60

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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

Section 50567-7 (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 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients, or to an antihistamine containing hydroxyzine.

Section 51727-6 (51727-6)

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

• if breast-feeding: Not recommended

• if pregnant: Ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Antihistamine



Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Section 60561-8 (60561-8)

Other information

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

Principal Display Panel

NDC: 51655-842-60

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:42.721846 · Updated: 2026-03-14T23:14:03.597898