CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride tablet 
Aurohealth LLC

----------

Cetirizine Hydrochloride Tablets USP 10 mg


 
 


Drug Facts

Cetirizine hydrochloride 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 tablet once daily; do not take more than one 10 mg tablet 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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?


call 1-855-274-4122

Keep the carton. It contains important information.

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (365's Tablet Bottle)

NDC 58602-823-39
Primary Health
Allergy Relief
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine                                       
Original Prescription Strength


365 Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (Container Carton Label)

NDC 58602-823-39
Primary Health
COMPARE TO Zytec®
active ingredient*
Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
24 hour Relief of

365 Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (Container Carton Label)


CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-823
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code X;36
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-823-091 in 1 CARTON08/05/201512/04/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-823-191 in 1 CARTON08/05/201504/02/2020
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-823-391 in 1 CARTON08/05/2015
3365 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-823) , MANUFACTURE(58602-823)

Revised: 1/2024
Document Id: bd9c2a41-9024-46a4-87c6-7d6f5f1fafbf
Set id: 7d214cba-951d-464e-b37e-e83098944fe6
Version: 4
Effective Time: 20240111
 
Aurohealth LLC