Childrens Cetirizine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Cetirizine Hydrochloride

Precision Dose Inc.

CHILDREN'S CETIRIZINE HYDROCHLORIDE ORAL SOLUTION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

5 mg/5 mL

Grape Flavor

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Childrens Cetirizine Hydrochloride 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.

Directions

  • use as directed per healthcare professional

Childrens Cetirizine Hydrochloride Other information

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

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

How Supplied

NDC 68094-720-62
5 mL per unit dose cup
Thirty (30) unit dose cups per shipper

Distributed By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

LI722
Rev. 12/08

PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Cup Lid Label

NDC 68094-720-59

PrecisionDose™

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

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

Childrens Cetirizine Hydrochloride

Childrens Cetirizine Hydrochloride

Cetirizine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68094-720(NDC:0113-0974)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACETIC ACID
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
SODIUM ACETATE
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-720-59 5 in 1 CUP, UNIT-DOSE
2 10 in 1 TRAY
3 NDC:68094-720-62 3 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090254 2009-03-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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