CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) - cetirizine hydrochloride tablet 
Aurohealth LLC

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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

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:


These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.


Do not use

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

Ask a doctor before use if you have

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

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 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet 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

Important: Read all product information before using. Keep this carton for important information.

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

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

AUROHEALTH

NDC 58602-446-09

*Compare to the active
ingredient of Zyrtec®

HIVES RELIEF

Cetirizine Hydrochloride Tablets USP
5 mg

Antihistamine
Original Prescription Strength

HIVES RELIEF
24 Hour relief        Reduces
                                Hives
30
Tablets                    Reduces Itching
5 mg each                Due to Hives
                                  

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 58602-446-21

*Compare to the active
ingredient of Zyrtec®

HIVES RELIEF

Cetirizine Hydrochloride Tablets USP
5 mg

Antihistamine
Original Prescription Strength

HIVES RELIEF
24 Hour relief        Reduces
                                Hives
100
(10x10's)
Unit dose Tablets         Reduces Itching
5 mg each                      Due to Hives


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 58602-447-09

*Compare to the active
ingredient of Zyrtec®

HIVES RELIEF

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine
Original Prescription Strength

HIVES RELIEF
24 Hour relief        Reduces
                                Hives
30
Tablets                                            Reduces Itching
10 mg each    Actual Size               Due to Hives



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 58602-447-21

*Compare to the active
ingredient of Zyrtec®

HIVES RELIEF

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine
Original Prescription Strength

HIVES RELIEF
24 Hour relief        Reduces
                                Hives

100 Tablets                   
(10x10 Unit-dose)                                   Reduces Itching  
         
10 mg each                   Actual Size         Due to Hives

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


CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-446
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)  
CELLULOSE, MICROCRYSTALLINE (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:58602-446-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-446-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-446-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-446-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
5NDC:58602-446-2110 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 (HIVES RELIEF) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-447
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)  
CELLULOSE, MICROCRYSTALLINE (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:58602-447-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-447-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-447-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-447-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
5NDC:58602-447-2110 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 (HIVES RELIEF) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-813
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)  
CELLULOSE, MICROCRYSTALLINE (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:58602-813-091 in 1 CARTON08/05/2015
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-813-171 in 1 CARTON08/05/2015
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-813-9975 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
4NDC:58602-813-231 in 1 CARTON08/05/2015
4120 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-813-391 in 1 CARTON08/05/2015
5365 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-813-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
7NDC:58602-813-0410 in 1 CARTON; Type 0: Not a Combination Product08/05/2015
8NDC:58602-813-8310 in 1 BLISTER PACK; Type 0: Not a Combination Product08/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)

Revised: 2/2025
Document Id: 5ebdf17c-288b-4fed-89c8-7d1f42a128d0
Set id: 2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a
Version: 6
Effective Time: 20250210
 
Aurohealth LLC