Cetirizine description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetirizine

Rebel Distributors Corp

Cetirizine HCl Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Cetirizine HCl 5mg

Keep Out of Reach of Children

Purpose

Cetirizine 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

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

Cetirizine

Cetirizine

Cetirizine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21695-878(NDC:24385-188)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACETIC ACID
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
SODIUM ACETATE
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-878-04 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078398 2008-06-17


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Be sure to consult your doctor before taking any medication!
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