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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: 65162-003

Cetirizine Hydrochloride Oral Solution
Antihistamine/ Hives Relief
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

relieves itching due to hives (urticaria). This product will not prevent hives or a allergic skin reaction from occurring.

WARNINGS

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • swelling of tongue
  • trouble speaking
  • wheezing or problems breathing
  • dizziness or loss of consciousness
  • swelling in or around the mouth
  • drooling

The symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a substitute for Epinephrine. If your doctor has prescribed an epinephrine injection for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause

  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 56 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
 children under 6 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:65162-003
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:65162-003-861 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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