CHILDRENS  CETIRZINE- cetirizine hydrochloride solution 
Pharmacy Value Alliance LLC

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Childrens
Cetirzine

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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

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. (1-800-222-1222)

Directions

adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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

Inactive ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Questions?

Call 1-866-923-4914

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

COMPARE TO THE
ACTIVE INGREDIENT
IN CHILDREN'S ZYRTEC®*

Premier
Value®

2 Yrs.
& older

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL

Antihistamine

Allergy

SUGAR FREE
BUBBLE GUM
flavor

INDOOR & OUTDOOR ALLERGIES

24 Hour Relief of:

Dosing Cup
Included

4 FL OZ
(120 mL)

INDEPENDENTLY TESTED
SATISFACTION GUARANTEED
PV

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS   CETIRZINE
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-106
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
acetic acid (UNII: Q40Q9N063P)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium acetate anhydrous (UNII: NVG71ZZ7P0)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score     
Shape Size
Flavor BUBBLE GUM (Sugar Free) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-106-08 1 in 1 CARTON 05/20/2011
1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201546 05/20/2011
Labeler - Pharmacy Value Alliance LLC (101668460)

Revised: 6/2017
Document Id: 51b02412-ebbd-4045-8af4-4b8b8e90daf4
Set id: 6b22f568-7ebd-4479-b764-6e5481d8c15a
Version: 3
Effective Time: 20170612
 
Pharmacy Value Alliance LLC