CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride tablet 
SDA Laboratories, Inc.

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SDA LABORATORIES - CETIRIZINE HYDROCHLORIDE TABLETS - 10 MG

ACTIVE INGREDIENT (IN EACH TABLET)

CETIRIZINE HYDROCHLORIDE 10 MG

PURPOSE

ANTIHISTAMINE

USE

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 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
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 toll free 1-800-687-0176
Mon – Fri 8 am to 5 pm

01b LBL_Cetirizine HCl Tablets_10mg_500ct_PDP

01b LBL_Cetirizine HCl Tablets_10mg_100ct_PDP

01b LBL_Cetirizine HCl Tablets_10mg_500ct_DF1

01b LBL_Cetirizine HCl Tablets_10mg_500ct_DF2

CETIRIZINE HYDROCHLORIDE  10 MG
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-564
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLE (ROUNDED-OFF RECTANGLE) Size10mm
FlavorImprint Code G4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-564-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
2NDC:66424-564-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927404/27/2021
Labeler - SDA Laboratories, Inc. (948067889)

Revised: 4/2021
Document Id: 30b513fa-482e-437b-ba46-8ffd570e63a6
Set id: 222a7e77-33a6-44ca-9ab1-0bc4fc431aa3
Version: 3
Effective Time: 20210427
 
SDA Laboratories, Inc.