CETIRIZINE HYDROCHLORIDE- cetirizine solution 
Amneal Pharmaceuticals LLC

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Cetirizine Hydrochloride Oral Solution
Antihistamine/ Allergy
1 mg/mL

*Compared to Children’s Zyrtec® active ingredient

Drug Facts

ACTIVE INGREDIENT

(in each 5 mL teaspoonful) 

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breastfeeding:

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help of contact a Poison Control Center right away. (1-800-222-1222)

Directions

 adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
 adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
 children 2 to under 6 years of age  ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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)
  • TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

INACTIVE INGREDIENTS

Sucrose, Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sodium Acetate, Glacial Acetic Acid, Artificial Grape Flavor, Purified Water.

Questions?

Call 1-877-835-5472

Monday through Friday 9AM – 5PM EST.

*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec® . Zyrtec® is a registered trademark of UCB Pharma, S.A.

Distributed by: Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 03-2015-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mg/mL Label

1 mg/mL Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-005
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
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (CLEAR TO PALE YELLOW) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-005-861 in 1 CARTON10/07/2009
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076510/07/2009
Labeler - Amneal Pharmaceuticals LLC (123797875)

Revised: 12/2023
Document Id: fa346360-b8c7-4238-ab67-f9ad56c9212f
Set id: e01f0db4-1b49-4b6e-b2fc-61834897bdd3
Version: 11
Effective Time: 20231218
 
Amneal Pharmaceuticals LLC