CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Direct_Rx

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CETIRIZINE HYDROCHLORIDE

Active Ingredients (in each tablet) Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine


Antihistamine

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

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat


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.

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery.


Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.

if breast-feeding: not recommended
if pregnant: ask a health professional before use.


In case of overdose, get medical help or contact Poison Control Center right away.

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

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]


Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.


Call 1-866-562-4597

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India


Distributed by:

Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

M. L. G/1430 May 2018

120005

538-90

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-538(NDC:16571-402)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
Colorwhite ((White)) Scoreno score
ShapeBULLET ((Barrel Shaped)) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-538-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/14/201910/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782908/14/201910/09/2023
Labeler - Direct_Rx (079254320)
Registrant - Direct_Rx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct_Rx079254320repack(61919-538)

Revised: 10/2023
 
Direct_Rx