CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Preferred Pharmaceuticals, Inc.

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Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

ACTIVE INGREDIENTS

Active Ingredients (in each tablet)                                                Purpose

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

PURPOSE

Antihistamine

USES

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

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

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

STOP USE

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

IF PREGNANT OR BREAST FEEDING:

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

KEEP OUT OF REACH OF CHILDREN

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

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

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

INACTIVE INGREDIENTS

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

QUESTIONS?

Call 1-844-874-7464

Manufactured by:

Unique Pharmaceutical Labs.

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


Distributed by:

Rising Pharma holdings, Inc.
East Brunswick, NJ 08816

 

M. L. G/1430    Jul. 2020

 

126406

Repackaged By: Preferred Pharmaceuticals Inc

PRINCIPAL DISPLAY PANEL-100'S COUNT

———PRINCIPAL DISPLAY PANEL———
Rising®

Repackaged By: Preferred Pharmaceuticals Inc

NDC 68788-0790
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older

Cetirizine Hydrochloride Tablet 10mg


CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0790(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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
starch, corn (UNII: O8232NY3SJ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-0790-114 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
2NDC:68788-0790-515 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
3NDC:68788-0790-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
4NDC:68788-0790-660 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
5NDC:68788-0790-990 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
6NDC:68788-0790-0100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0790)

Revised: 3/2024
Document Id: 00b5227f-c3b8-43e8-812c-6e4be9a951d4
Set id: 3fc53b32-704b-4586-aa8c-26a2a71a155a
Version: 13
Effective Time: 20240325
 
Preferred Pharmaceuticals, Inc.