CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) - cetirizine hydrochloride capsule 
Aurohealth LLC

----------

Cetirizine HCl Capsules 10 mg (Hives Relief)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCI USP 10 mg

Purpose


Antihistamine

Uses


relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:


These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.


Do not use

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

Ask a doctor before use if you have


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

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
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

HIVES Relief     NDC 58602-808-04
Original Prescription Strength

Cetirizine HCl Capsules
10 mg                                             CZ10
Antihistamine                            (Actual Size) 

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

12 LIQUID GELS*

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Carton Label)

NDC 58602-808-04
*Compare to the active ingredient in Zyrtec®
Original Prescription Strength
HIVES Relief

Cetirizine HCl Capsules

10 mg
Antihistamine

24 hour                                                      CZ10

Relief of itching due to hives               (Actual Size)

12 LIQUID GELS*

* LIQUID-FILLED CAPSULES
AUROHEALTH


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (Carton Label)
CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-808
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:58602-808-041 in 1 CARTON07/20/2018
112 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-808-531 in 1 CARTON07/20/2018
225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-808-121 in 1 CARTON07/20/2018
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-808-1665 in 1 CARTON07/20/2018
465 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910707/20/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-808) , MANUFACTURE(58602-808)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-808) , MANUFACTURE(58602-808)

Revised: 9/2020
Document Id: 30494d65-a846-4f13-a076-242f193e4651
Set id: f0f486e1-2eeb-4eaa-b557-908bcbf973a8
Version: 4
Effective Time: 20200914
 
Aurohealth LLC