Cetirizine Hydrochloride Tablets Usp, 10 Mg

Cetirizine Hydrochloride Tablets Usp, 10 Mg
SPL v1
SPL
SPL Set ID 110adf3c-84ce-48a1-8a22-89ee3eec22d9
Route
ORAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-06-01

Description

Cetirizine HCI USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCI USP 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 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 51945-4

Section 53414-9

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use

Warnings:

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.

Directions

Adults and children 6 years and older: 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 Lnfonnation
  • store between 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).
Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch,polyethylene glycol, povidone, titanium dioxide

Questions Or Comments?

Call + 1 (732) 698 5070 & Email: [email protected]

Active Ingredient (in Each Tablet)

Cetirizine HCI 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
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 51945-4 (51945-4)

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

Warnings:

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.

Directions

Adults and children 6 years and older: 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 Lnfonnation (Other lnfonnation)
  • store between 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).
Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch,polyethylene glycol, povidone, titanium dioxide

Questions Or Comments? (Questions or Comments?)

Call + 1 (732) 698 5070 & Email: [email protected]

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

Cetirizine HCI USP 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)