CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride allergy tablet 
Cardinal Health

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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
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

Made in India

Code: TS/DRUGS/19/1993

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

LEADERTM

NDC 70000-0047-1

Original Prescription Strength
All Day Allergy
Cetirizine Hydrochloride Tablets
USP, 10 mg | Antihistamine

COMPARE TO
ZYRTEC®
active ingredient*

Indoor and
Outdoor Allergies
24-Hour Relief of:
Sneezing; Runny Nose; Itchy,
Watery Eyes; Itchy Throat or Nose

365 TABLETS
10 mg EACH



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (14's Tablet Blister Pack Label)
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride allergy tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0047
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:70000-0047-1365 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076003/26/2020
Labeler - Cardinal Health (063997360)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(70000-0047) , MANUFACTURE(70000-0047)

Revised: 6/2021
Document Id: 3516544d-5a68-417f-be0e-47914dd86b38
Set id: 0cab7aa8-ded3-46f1-b801-2663cc9b0173
Version: 3
Effective Time: 20210616
 
Cardinal Health