CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, coated 
Safrel Pharmaceuticals, LLC

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Cetrizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets

Drug Facts

Active Ingredient

Cetirizine HCl 10 mg

PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

liver or kidney disease. Your doctor should determine if you need a different dose.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

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.

PREGNANCY/BREASTFEEDING

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

STORAGE

Other information

◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Cetirizine

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-005
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 (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:71309-005-03300 in 1 BOTTLE; Type 0: Not a Combination Product05/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927405/28/2018
Labeler - Safrel Pharmaceuticals, LLC (080566287)

Revised: 10/2020
Document Id: b0c6821d-4a7f-b6a7-e053-2995a90a7b9c
Set id: b0c6821d-4a7e-b6a7-e053-2995a90a7b9c
Version: 1
Effective Time: 20201003
 
Safrel Pharmaceuticals, LLC