CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hcl solution 
Proficient Rx LP

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Major Pharmaceuticals Children’s Cetirizine Hydrochloride Oral Solution 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
sneezing
itchy, watery eyes
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 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

store between 20° to 25°C (68° to 77°F)
do not use if carton is opened, or if printed neckband is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

COMPARE TO the active ingredient of CHILDREN’S ZYRTEC®

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

ALLERGY

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing / Runny Nose

Itchy, Watery Eyes / Itchy Throat or Nose

4 FL OZ

24 Hour

(118 mL)

2yrs & older

Dosing Cup Included

Dye-Free

Sugar-Free

Grape Flavored Syrup

71205-722-04
CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-722(NDC:0904-6765)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-722-041 in 1 CARTON11/17/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422608/22/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-722) , RELABEL(71205-722)

Revised: 11/2022
Document Id: 8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e
Set id: 8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e
Version: 1
Effective Time: 20221101
 
Proficient Rx LP