Childrens Cetirizine Oral Solution

CHILDREN'S

CETIRIZINE

HYDROCHLORIDE

ORAL SOLUTION

1 mg/1 mL

Antihistamine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose


• itchy, watery eyes


• sneezing


• itching of the nose or throat

Warnings

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.

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

• use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

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

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose

Questions?

Call 1-866-923-4914

Distributed by: Chain Drug Consortium, LLC

2300 NW Corporate BLVD., Suite 115

Boca Raton, FL 33431

Made in Israel

PRINCIPAL DISPLAY PANEL - 120 mL bottle carton

NDC 68016-023-43

Ages

two years

and older

Compare to

the active ingredient

in Children's Zyrtec®*

Premier

Value®

CHILDREN'S

CETIRIZINE

HYDROCHLORIDE

ORAL SOLUTION

1 mg/1 mL

Antihistamine

Grape Flavored Syrup

24 hour Allergy Relief of:

Sneezing; Runny Nose;

Itchy,Watery Eyes;

Itchy Throat or Nose

Indoor & Outdoor Allergies

Dosing Cup

Included

PV

PREMIER VALUE GUARANTEE

4 FL OZ (120 mL)

CHILDRENS CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride  solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68016-023 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength acetic acid   glycerin   methylparaben   propylene glycol   propylparaben   water   sodium acetate anhydrous   sucrose

Product Characteristics Color YELLOW (colorless to slightly yellow) Score      Shape Size Flavor GRAPE, BANANA Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68016-023-43 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (68016-023-43)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090182	04/22/2008

Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceutical Industries Ltd.		600072078	ANALYSIS, MANUFACTURE

Revised: 04/2010Chain Drug Consortium, LLC (Premier Value)

More Childrens Cetirizine Oral Solution resources

• Childrens Cetirizine Oral Solution Side Effects (in more detail)
• Childrens Cetirizine Oral Solution Use in Pregnancy & Breastfeeding
• Drug Images
• Childrens Cetirizine Oral Solution Drug Interactions
• Childrens Cetirizine Oral Solution Support Group
• 73 Reviews for Childrens Cetirizine - Add your own review/rating

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