CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride capsule 
Aurohealth LLC

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Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl USP 10 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

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

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
one 10 mg capsule once daily;
do not take more than one 10 mg
capsule in 24 hours. A 5 mg
product may be appropriate for
less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or
kidney disease
ask a doctor


Other information


Inactive ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
 

Made in India 
Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label)

PrimaryHealth            NDC 58602-863-12
ALLERGY
Original
Prescription Strength

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR + OUTDOOR ALLERGIES

40 LIQUID GELS*
* LIQUID-FILLED CAPSULES
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label)

NDC 58602-863-12
PrimaryHealth
COMPARE TO Zyrtec®
active ingredient*
Original Prescription Strength
 ALLERGY      

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR  ALLERGIES

24 HOUR
RELIEF OF

CZ10
(Actual size)

40 LIQUID GELS*
* LIQUID-FILLED CAPSULES
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-863
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorYELLOW (Clear colourless to pale yellow viscous liquid) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code CZ10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-863-121 in 1 CARTON03/12/2021
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910703/12/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-863) , MANUFACTURE(58602-863)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-863) , MANUFACTURE(58602-863)

Revised: 3/2021
Document Id: 0b6e8c63-a76c-4184-a9cc-9691378c3ee5
Set id: 0b6e8c63-a76c-4184-a9cc-9691378c3ee5
Version: 1
Effective Time: 20210311
 
Aurohealth LLC