CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY- cetirizine hydrochloride solution

Childrens Cetirizine Hydrochloride Allergy by

Drug Labeling and Warnings

Childrens Cetirizine Hydrochloride Allergy by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine hydrochloride USP 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 only with enclosed dosing cup
• find right dose on chart below
• mL = Milliliter

• 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 over: 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)
• Do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive ingredients

cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

Questions?

call 1-855-274-4122

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if cap safety seal is broken or missing.

Manufactured for:
AUROHEALTH LLC,
 2572 Brunswick Pike,
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)

AUROHEALTH

NDC: 58602-028-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

2 yrs.& older
Cherry Flavor
Dye-Free 
4 fl oz (120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)

AUROHEALTH

NDC: 58602-028-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

2 yrs.& older
Cherry Flavor 
Dye-Free
4 fl oz (120 mL) Dosing Cup Included

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-028
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM ACETATE (UNII: 4550K0SC9B)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (Colorless to Pale Yellow)	Score
Shape		Size
Flavor	CHERRY (Cherry Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-028-24	1 in 1 CARTON	06/24/2015
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 58602-028-20	1 in 1 CARTON	06/24/2015
2		240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3	NDC: 58602-028-26	480 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	06/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090750	06/24/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-028) , MANUFACTURE(58602-028)