SPL v1
SPL
SPL Set ID 5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
Route
ORAL
Published
Effective Date 2017-01-03
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)

Identifiers & Packaging

Pill Appearance
Imprint: SZ;906 Shape: round Color: white Size: 8 mm
Marketing Status
ANDA Active Since 2017-01-03

Description

(in each tablet) Cetirizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

(in each tablet) Cetirizine HCl 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

Warnings

antihistamine containing hydroxyzine.

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

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

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

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

If pregnant or breast-feeding:



if breast-feeding: not recommended



if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

dults 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

Active Ingredient

(in each tablet)

Cetirizine HCl 10 mg

Inactive Ingredient

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label. Principal Display Panel


Structured Label Content

Uses (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

Purpose

Antihistamine

Warnings

antihistamine containing hydroxyzine.

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

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

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

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

If pregnant or breast-feeding:



if breast-feeding: not recommended



if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

dults 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

Active Ingredient

(in each tablet)

Cetirizine HCl 10 mg

Inactive Ingredient

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

Keep Out of Reach of Children (Keep out of Reach of Children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label. Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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