CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY - cetirizine hydrochloride solution
Aurobindo Pharma Limited

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Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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.

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 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)

Inactive ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions?

call 1-866-850-2876

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

Do not use if the cap safety seal is broken or missing.

Manufactured for:
AUROHEALTH
6 Wheeling Road
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

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

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

NDC 65862-422-12
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
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO

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

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

NDC 65862-422-12
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
Grape
Syrup
Dosing Cup
Included
4 fl oz (120 mL)
AUROBINDO

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

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65862-422
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	BANANA, GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65862-422-12	1 in 1 CARTON	02/02/2010	10/30/2019
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:65862-422-24	1 in 1 CARTON	02/02/2010	10/30/2019
2		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:65862-422-48	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2010	10/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090750	02/02/2010	10/30/2019

Labeler - Aurobindo Pharma Limited (650082092)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(65862-422) , MANUFACTURE(65862-422)

Revised: 10/2019

Document Id: be63a06d-48d1-43a9-a219-13d5b13d3107

Set id: ecbc32c3-6979-49e1-85bd-159065687e54

Version: 3

Effective Time: 20191030

Aurobindo Pharma Limited