OTC Medication Information: CVS Pharmacy Childrens Allergy Relief

CVS PHARMACY CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution
CVS Pharmacy

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 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 older 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)

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
(click image for full-size original)
CVS PHARMACY CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-276
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
acetic acid
glycerin
methylparaben
propylene glycol
propylparaben
water
sucralose
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor GRAPE (sugar free) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-276-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (59779-276-04)
2 NDC:59779-276-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 240 mL in 1 BOTTLE This package is contained within the CARTON (59779-276-01)
3 NDC:59779-276-08 1 BOTTLE in 1 CARTON contains a BOTTLE
3 120 mL in 1 BOTTLE This package is contained within the CARTON (59779-276-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090182 09/08/2011
Labeler — CVS Pharmacy (062312574)
Registrant — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (59779-276)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceticals Inc. 206263295 MANUFACTURE (59779-276)

Revised: 02/2013 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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