DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hydrochloride solution

Dye Free Childrens Cetirizine Hydrocholride by

Drug Labeling and Warnings

Dye Free Childrens Cetirizine Hydrocholride by is a Otc medication manufactured, distributed, or labeled by Precision Dose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• runny nose
• sneezing
• itchy, watery eyes
• 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 as directed per healthcare professional.
• mL = milliliter

• 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

• store between 20° to 25°C (68° to 77°F)
• See individual label or shipper for lot number and expiration date.

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Dye Free, Gluten Free, Sugar Free

How Supplied

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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)