CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE- cetirizine hydrochloride solution 
Proficient Rx LP

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Children's Cetirizine Hydrochloride Oral Solution
Sugar Free Grape

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:

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 (1-800-222-1222).

Directions

use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

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 older

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

do not use if carton is opened, or if imprinted safety seal is broken or missing
see bottom panel for expiration date
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), sucralose

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled by: Proficient Rx LP
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Compare to the
active ingredient
in Children's Zyrtec®*

NDC 71205-705-72

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL

ALLERGY
Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

2 Yrs. & older

Grape Flavor

Dosing Cup Included

4 FL OZ
(120 mL)

71205-705-72
CHILDRENS CETIRIZINE HYDROCHLORIDE  SUGAR FREE GRAPE
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-705(NDC:51672-2102)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    Score    
ShapeSize
FlavorGRAPE, BANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-705-721 in 1 CARTON10/13/2022
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018209/08/2011
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-705)

Revised: 10/2022
Document Id: 582db483-394e-4c00-8522-4041a11696e4
Set id: 582db483-394e-4c00-8522-4041a11696e4
Version: 1
Effective Time: 20221001
 
Proficient Rx LP