Cetirizine Hydrochloride Tablets Usp, 10mg

Cetirizine Hydrochloride Tablets Usp, 10mg
SPL v4
SPL
SPL Set ID 181c63dd-6ab8-909a-e063-6394a90af141
Route
ORAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2024-09-09

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 mg

Pdp

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

of age 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  ask a doctor

and over

children under  ask a doctor

6 years of age

consumers with  ask a doctor

liver or kidney

disease

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 Mon-Fri 8:00 AM EST to 5:00 PM PST

Other Information

 store between 20° and 25°C (68° and 77°F)

 contains no ingredient made from a glutencontaining grain (wheat, barley or rye)

Inactive Ingredients

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

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.

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)

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

Pdp (PDP)

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

of age 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  ask a doctor

and over

children under  ask a doctor

6 years of age

consumers with  ask a doctor

liver or kidney

disease

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 Mon-Fri 8:00 AM EST to 5:00 PM PST

Other Information (Other information)

 store between 20° and 25°C (68° and 77°F)

 contains no ingredient made from a glutencontaining 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

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.

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

 if breast-feeding: not recommended

 if pregnant: ask a health professional before use

Keep Out of Reach of Children. (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)

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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