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 HCI 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

gelatin, glycerin, polyethylene 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 (65's Capsule Container Label)

Healthy LivingTM

Allergy                         Original Prescription Strength

CETIRIZINE HCl
Capsules 10 mg
Antihistamine
Indoor + Outdoor Allergies

READ AND KEEP THE OUTER PACKAGE FOR            65 LIQUID GELS*
COMPLETE WORNINGS AND INFORMATION          *liquid-filled capsules  
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)
                          
                                                                                                                                              


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label)

Healthy LivingTM

Allergy                       Original Prescription Strength

CETIRIZINE HCl
Capsules 10 mg
Antihistamine
Indoor + Outdoor Allergies                            *Compare
                                                                     to the Active
                                                                     Ingredient in                  CZ10
                                                                        Zyrtec®                             (Actual Size)     
 
24 Hour Relief of: • Sneezing • Runny Nose                      65 Liquid Gels*
• Itchy, Watery Eyes • Itchy Throat or Nose                     *liquid-filled capsules

figure

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-716
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
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:58602-716-161 in 1 CARTON08/16/2022
165 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910708/16/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-716) , MANUFACTURE(58602-716)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-716) , MANUFACTURE(58602-716)

Revised: 8/2022
Document Id: 1bbefda2-d3c5-4d31-b3ec-7da077e41157
Set id: 1bbefda2-d3c5-4d31-b3ec-7da077e41157
Version: 1
Effective Time: 20220816
 
Aurohealth LLC