CHILDRENS ZYRTEC HIVES RELIEF- cetirizine hydrochloride syrup 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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

These 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 injector 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 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

  • use only with enclosed dosing cup
adults and children 6 years and over1 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 over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or if bottle wrap printed with "Safety Seal®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

NDC 50580-731-05

Children's
ZYRTEC
®
HIVES
Relief

Cetirizine HCl
1 mg /mL oral
solution antihistamine

24
hour

Relief of
ITCHING
Due to
Hives

6 yrs.
& older

Grape
Syrup

Dye-Free • Sugar-Free

4 FL OZ (118 mL)

Dosing Cup Included

PRINCIPAL DISPLAY PANEL
CHILDRENS ZYRTEC HIVES RELIEF 
cetirizine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-731
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
anhydrous citric acid 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-731-051 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02215507/01/200902/29/2012
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 08/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc