Your browser does not support JavaScript! CVS PHARMACY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY]
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CVS PHARMACY CHILDRENS ALLERGY RELIEF (cetirizine hydrochloride) solution
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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
  • itchy, watery eyes
  • sneezing
  • itching of the nose or 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 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 older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age½ 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

Questions?

Call 1-866-923-4914

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

CVS
pharmacy®

NDC 59779-276-04

Compare to the active
ingredient in Children's ZYRTEC®*

Original Prescription Strength

24
HOUR

INDOOR & OUTDOOR
ALLERGIES

NEW!

Children's
ALLERGY
RELIEF

CETIRIZINE HYDROCHLORIDE
ORAL SOLUTION 1mg/mL ANTIHISTAMINE

24 hour relief of:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Itchy throat
    & nose

Sugar free
Dye free
2 yrs. & older
Dosing cup included

2 FL OZ
(60 mL)

Grape Flavor

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
CVS PHARMACY   CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-276
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 
water 
sucralose 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-276-041 in 1 CARTON
160 mL in 1 BOTTLE
2NDC:59779-276-011 in 1 CARTON
2240 mL in 1 BOTTLE
3NDC:59779-276-081 in 1 CARTON
3120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018209/08/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(59779-276)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceticals Inc.206263295MANUFACTURE(59779-276)

Revised: 2/2013
 
CVS Pharmacy

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