CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride tablet 
NorthStar Rx LLC

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Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 
Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

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 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 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

Inactive ingredients

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

Questions?

call 1-800-206-7821

 

Manufactured for: Northstar Rx LLC

                           Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

                           Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 03/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label)

NDC 16714-799-04
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine
ALLERGY RELIEF
Original Prescription Strength

Indoor & Outdoor Allergies
24 Hour Relief of :

• Sneezing          • Runny Nose

• Itchy, Watery Eyes     • Itchy Throat or Nose

                                                          500 Tablets

                                                          10 mg each


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label)

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-799
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code X;36
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16714-799-0130 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
2NDC:16714-799-02100 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
3NDC:16714-799-03300 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
4NDC:16714-799-04500 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - NorthStar Rx LLC (830546433)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(16714-799) , MANUFACTURE(16714-799)

Revised: 10/2022
Document Id: 7bfd8f80-7f76-4de7-9c7e-b86cda46cb5b
Set id: c9d1e26f-c95a-4991-95fa-9ed6ed484fe2
Version: 3
Effective Time: 20221029
 
NorthStar Rx LLC