CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride tablet 
Aurohealth LLC

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Cetirizine Hydrochloride Tablets USP 10 mg


Drug Facts

Active ingredient (in each tablet)

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

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

Made in India


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Bottle)

Healthy Living™

ALLERGY RELIEF
CETIRIZINE HYDROCHLORIDE
Tablets USP 10 mg

Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
10 mg Strength Tablets

*Compare
to the Active
I
ngredient in
Zyrtec®

24 Hour Relief of:
• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

500
Tablets
10 mg each

  PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Bottle)

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-861
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:58602-861-211 in 1 CARTON02/10/202304/17/2023
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-861-291 in 1 CARTON02/10/202301/11/2024
2150 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-861-40500 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076002/10/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-861) , MANUFACTURE(58602-861)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-861) , MANUFACTURE(58602-861)

Revised: 5/2026
Document Id: 20dddc76-5ac2-498d-bff3-2d722a58891e
Set id: c1ae7bb1-e154-4745-b01e-bc91d50d35c8
Version: 3
Effective Time: 20260525
 
Aurohealth LLC