CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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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

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

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:

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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk 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 1-866-562-4597

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


Principal Display Panel

NDC: 70934-199-90

Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70934-199(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)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (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:70934-199-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/201809/30/2024
2NDC:70934-199-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/201903/31/2024
3NDC:70934-199-97100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/201910/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782912/04/201809/30/2024
Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals080355546repack(70934-199)

Revised: 1/2023
Document Id: f1629845-7641-10b6-e053-2995a90ae98c
Set id: 7ea2c5d8-d880-7d07-e053-2991aa0a2353
Version: 3
Effective Time: 20230103
 
Denton Pharma, Inc. DBA Northwind Pharmaceuticals