CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
QUAGEN PHARMACEUTICALS LLC

----------

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

PRINCIPAL DISPLAY PANEL - Bubble Gum Flavor - Container Label

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Bubblegum Flavor - Label

PRINCIPAL DISPLAY PANEL - Bubble Gum Flavor - Carton Label

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Bubblegum Flavor - Carton Label

PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label

PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70752-103
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
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70752-103-061 in 1 CARTON05/17/2019
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21226605/17/2019
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:70752-104-061 in 1 CARTON05/17/2019
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21226605/17/2019
Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)
Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)
Establishment
NameAddressID/FEIBusiness Operations
QUAGEN PHARMACEUTICALS LLC080281331manufacture(70752-103, 70752-104) , pack(70752-103, 70752-104)

Revised: 5/2019
Document Id: 99d36268-aa94-41e4-8629-a173ff21a405
Set id: 9163cd2e-0be7-4009-b905-729014773d6e
Version: 3
Effective Time: 20190517
 
QUAGEN PHARMACEUTICALS LLC