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Cetirizine Hydrochloride by Amneal Pharmaceuticals of New York, LLC

Medically reviewed on March 5, 2018

Dosage form: solution
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg in 5mL
Labeler: Amneal Pharmaceuticals of New York, LLC
NDC Code: 65162-005

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:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose and 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 breastfeeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use

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

CETIRIZINE HYDROCHLORIDE 
cetirizine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM ACETATE 
SUCROSE 
WATER 
Product Characteristics
ColorYELLOW (CLEAR TO PALE YELLOW) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65162-005-861 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076510/07/2009
Labeler - Amneal Pharmaceuticals of New York, LLC (123797875)

 
Amneal Pharmaceuticals of New York, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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