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

Description

Active ingredient (in each tablet) Cetirizine Hydrochloride 10 mg

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

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

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

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg

Other Information

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


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

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

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

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg

Other Information (Other information)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)