CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Bryant Ranch Prepack

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Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor)

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children.

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.
  • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

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 over5 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 Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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

Questions?

Call 1-888-344-9603 (toll-free)

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

51001 & 51002
Rev. 10/18

HOW SUPPLIED

NDC: 72162-2073-2: 118 mL in a BOTTLE

Store between 20° to 25°C (68° to 77°F)

Protect from light

do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing

Cetirizine Hydrochloride Oral Solution

Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72162-2073(NDC:70752-104)
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
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:72162-2073-21 in 1 CARTON08/15/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21226610/15/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(72162-2073) , RELABEL(72162-2073)

Revised: 8/2023
Document Id: 9b6fed2b-325d-4892-9aab-056967882c57
Set id: 9c11dd22-cb17-4179-8c54-1d515bf662d2
Version: 101
Effective Time: 20230829
 
Bryant Ranch Prepack