CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride tablet 
Aurohealth LLC

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Cetirizine Hydrochloride Tablets (Allergy)


Drug Facts

Active ingredient (in each tablet)


For 5 mg:

Cetirizine hydrochloride USP 5 mg

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 5 mg:

adults and children 6 years and over
1 tablet (5 mg) or
2 tablets (10 mg) once
daily depending upon
severity of symptoms; do
not take more than
2 tablets (10 mg) in
24 hours.
adults 65 years and over
1 tablet (5 mg) once 
daily; do not take more
than 1 tablet (5 mg) in
24 hours.
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

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

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown,
East Windsor, NJ 08520

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

AUROHEALTH

NDC 58602-444-09

*Compare to the active
ingredient of Zyrtec®

Original Prescription Strength

Allergy Relief
Cetirizine Hydrochloride
Tablets USP 5 mg

Antihistamine

Indoor & Outdoor Allergies
5 mg Strength Tablets

Take 1 to 2 tablets* once daily
depending on the severity of
your symptoms

*Adults 65 and older take only
one tablet per day

24 Hour relief of

30 Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)

AUROHEALTH

NDC 58602-444-21

*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 5 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
5 mg Strength Tablets

Take 1 to 2 tablets* once daily depending
on the severity of your symptoms

*Adults 65 and older take only one tablet per day

24 Hour relief of

100 (10 x 10)
unit-dose Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)


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

AUROHEALTH

NDC 58602-445-09

*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
10 mg Strength Tablets

24 Hour relief of

30 Tablets
10 mg each

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

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

AUROHEALTH

NDC 58602-445-21

*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
10 mg Strength Tablets

24 Hour relief of

100 (10x10) Tablets
10 mg each

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

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-444
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 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
ShapeROUNDSize6mm
FlavorImprint Code X;35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-444-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-444-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-444-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-444-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
5NDC:58602-444-2110 in 1 CARTON08/05/2015
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-445
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:58602-445-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-445-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-445-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-445-151 in 1 CARTON08/05/2015
460 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-445-191 in 1 CARTON08/05/2015
590 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-445-941 in 1 CARTON08/05/2015
6100 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-445-381 in 1 CARTON08/05/2015
7300 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-445-40500 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
9NDC:58602-445-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
10NDC:58602-445-2110 in 1 CARTON08/05/2015
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:58602-445-011 in 1 CARTON08/05/2015
1114 in 1 BLISTER PACK; Type 0: Not a Combination Product
12NDC:58602-445-601 in 1 CARTON08/05/2015
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
13NDC:58602-445-541 in 1 CARTON08/05/2015
1370 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:58602-445-652 in 1 CARTON11/21/2019
147 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-812
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) Score2 pieces
ShapeRECTANGLE (off-rectangular) Size9mm
FlavorImprint Code X;2;0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-812-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-812-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-812-9975 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-812-231 in 1 CARTON08/05/2015
4120 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-812-391 in 1 CARTON08/05/2015
5365 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-812-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
7NDC:58602-812-0410 in 1 CARTON08/05/2015
7NDC:58602-812-8310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-444, 58602-445, 58602-812) , MANUFACTURE(58602-444, 58602-445, 58602-812)

Revised: 3/2024
Document Id: efcbe761-9e17-4641-8bf7-467067dcb2a0
Set id: 3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25
Version: 10
Effective Time: 20240304
 
Aurohealth LLC