3579

3579
SPL v2
SPL
SPL Set ID 84459f11-3405-4a8e-be38-333b7de2a578
Route
oral
Published
Effective Date 2025-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetirizine (10 mg)
Inactive Ingredients
lactose monohydrate starch, corn povidone k30 magnesium stearate titanium dioxide hypromelloses polyethylene glycol 400 polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: C;2 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
anda active Since 2025-04-16

Description

Active ingredient (in each tablet) Cetirizine Hydrochloride 10 mg


Medication Information

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

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° to 25°C (68° to 77°F).

Description

Active ingredient (in each tablet) Cetirizine Hydrochloride 10 mg

Section 42229-5

DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

Contract Pharmacal Corp.

165 Oser Avenue

Hauppauge, NY 11788 USA

www.cpc.com

* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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 sedatives or tranquilizers.

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 51727-6

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

Section 51945-4

NDC 10267-3579-6

*Compares to Zyrtec®Allergy Original Prescription Strength

Allergy

Cetirizine HCl Tablets, USP

10mg/ Antihistamine

Indoor & Outdoor Allergies

24 Hour

RELIEF OF

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

365 Tablets

10 mg each

Section 53413-1

1-800-231-4670

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

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 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

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 (Other information)

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

Section 42229-5 (42229-5)

DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

Contract Pharmacal Corp.

165 Oser Avenue

Hauppauge, NY 11788 USA

www.cpc.com

* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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 are taking sedatives or tranquilizers.

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 51727-6 (51727-6)

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

Section 51945-4 (51945-4)

NDC 10267-3579-6

*Compares to Zyrtec®Allergy Original Prescription Strength

Allergy

Cetirizine HCl Tablets, USP

10mg/ Antihistamine

Indoor & Outdoor Allergies

24 Hour

RELIEF OF

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

365 Tablets

10 mg each

Section 53413-1 (53413-1)

1-800-231-4670

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

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)