24h

24h
SPL v7
SPL
SPL Set ID 9f04520e-161d-3f7b-e053-2a95a90a678d
Route
ORAL
Published
Effective Date 2020-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Hypromelloses Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2020-04-21 Until 2024-12-31

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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

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

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.

Questions?

call 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST.

Other Information

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

■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Principal Display Panel

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.

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)

If Pregnant Or Breast Feeding:

■ if breast-feeding: not recommended

■ if pregnant: ask a health professional before use

Active Ingredient (in Each Tablet)



Cetirizine HCl 10 mg

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.


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

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

Do Not Use (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.

Questions?

call 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST.

Other Information (Other information)

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

■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Principal Display Panel

When Using This Product (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 (Stop use and ask a doctor if)

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

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. (1-800-222-1222)

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

■ if breast-feeding: not recommended

■ if pregnant: ask a health professional before use

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



Cetirizine HCl 10 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.


Advanced Ingredient Data


Raw Label Data

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