CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, coated 
NCS HealthCare of KY, LLC dba Vangard Labs

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Cetrizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets

Drug Facts

Active Ingredient (in each tablet)

Cetirizine HCl 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 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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION

Inactive ingredients

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

QUESTIONS?

call 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-8479(NDC:70010-163)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeRECTANGLE (rounded off rectangualr) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0615-8479-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product07/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927401/13/2022
Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-8479)

Revised: 6/2024
Document Id: 1125df7c-ba82-46fe-a411-05322146a3b9
Set id: b53d5e8a-a30c-4025-aa72-d2776a112e3e
Version: 2
Effective Time: 20240624
 
NCS HealthCare of KY, LLC dba Vangard Labs