CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet 
BluePoint Laboratories

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CETIRIZINE HCL Tablets USP


Drug Facts

Active ingredient (in each tablet)


For 10 mg:



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

For 10 mg:

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 1-855-274-4122


Manufactured by:

Aurobindo Pharma Limited
Hyderabad-500 090, India
For BluePoint Laboratories


Made in India


Code: TS/DRUGS/19/1993

Issued 05/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

Cetirizine Tab 10mg 30 ct

NDC 68001-436-04

*Compare to the active

ingredient of Zyrtec ®



Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength



Indoor & Outdoor Allergies

24 Hour Relief of :

30 Tablets

10 mg each


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

Cetirizine tab 10x10 ct blister pack

NDC68001-436-96

*Compare to the active

ingredient of Zyrtec ®



Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength



Indoor & Outdoor Allergies

24 Hour Relief of :

100 (10x10) Tablets

10 mg each

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-436
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:68001-436-961 in 1 CARTON06/19/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68001-436-041 in 1 CARTON06/19/2020
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68001-436-971 in 1 CARTON06/19/2020
3300 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68001-436-1610 in 1 BLISTER PACK; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076006/19/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642analysis(68001-436) , manufacture(68001-436)

Revised: 3/2024
Document Id: 139fa511-a9d1-d53d-e063-6294a90afa02
Set id: a86fbe45-08db-bddf-e053-2a95a90aa792
Version: 3
Effective Time: 20240314
 
BluePoint Laboratories