DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hydrochloride solution 
Precision Dose, Inc.

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DYE FREE CHILDREN'S CETIRIZINE HYDROCHLORIDE
ORAL SOLUTION

Grape Flavor

5 mg/5 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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

Inactive ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Dye Free, Gluten Free, Sugar Free

How Supplied

NDC 68094-004-62
5 mL per unit dose cup
Thirty (30) cups per shipper

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI1060 Rev. 05/16

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-004-59
PrecisionDose ™

Children's CETIRIZINE HCl
Oral Solution
5 mg/5 mL
DYE
FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE 
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-004(NDC:0113-0503)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-004-62 3 in 1 CASE 10/26/2016
1 10 in 1 TRAY
1 NDC:68094-004-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204226 10/26/2016
Labeler - Precision Dose, Inc. (035886746)

Revised: 11/2016
Document Id: ad976192-fd11-49d6-84f5-b619a78ef3ab
Set id: 6a7c4dff-66c6-4d0c-af10-d908c65a43be
Version: 1
Effective Time: 20161117
 
Precision Dose, Inc.