Cetirizine Hcl Drug Facts

Cetirizine Hcl Drug Facts
SPL v1
SPL
SPL Set ID 5e652955-bce3-4b0a-a754-739712725aaf
Route
ORAL
Published
Effective Date 2011-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Acetic Acid Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Acetate Sucrose Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2008-06-17

Description

Cetirizine HCl 5mg


Medication Information

Description

Cetirizine HCl 5mg

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

Do not use if you have ever had a allergic reaction to this product or any of its ingredients or to an 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.

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

Directions

Use only with enclosed dosing cup:

Adults and children 6 years and over: 1 teaspoonful (5ml) or 2 teaspoonfuls (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10ml) in 24 hours.

Adults 65 years and over: 1 teaspoonful (5mo) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours.

Children 2 to under 6 years of age:

1/2 teaspoonful (2.5ml) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5mo) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours.

Children under 2 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

Active Ingredient

Cetirizine HCl 5mg

Other Information

Do not use if carton is opened, or if printed neckband is broken or missing.

Questions or comments?

Call 1-800-719-9260

Store between 20° to 25°C (68° to 77°F)

Dosing cup should be washed and left to air dry after each use.

Inactive Ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Distributed by:

AmerisourceBergen

Valley Forge, PA 19482-0959

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/label Principal Display Panel


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

Warnings

Do not use if you have ever had a allergic reaction to this product or any of its ingredients or to an 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.

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

Directions

Use only with enclosed dosing cup:

Adults and children 6 years and over: 1 teaspoonful (5ml) or 2 teaspoonfuls (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10ml) in 24 hours.

Adults 65 years and over: 1 teaspoonful (5mo) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours.

Children 2 to under 6 years of age:

1/2 teaspoonful (2.5ml) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5mo) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours.

Children under 2 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

Active Ingredient (Active ingredient)

Cetirizine HCl 5mg

Other Information

Do not use if carton is opened, or if printed neckband is broken or missing.

Questions or comments?

Call 1-800-719-9260

Store between 20° to 25°C (68° to 77°F)

Dosing cup should be washed and left to air dry after each use.

Inactive Ingredients (Inactive ingredients)

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Distributed by:

AmerisourceBergen

Valley Forge, PA 19482-0959

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/label Principal Display Panel (Package/Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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