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Cetirizine Hydrochloride (Hives Relief)

Medically reviewed on Mar 6, 2017

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Aurohealth LLC
NDC Code: 58602-446


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

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:


  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

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
  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

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.

  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve after 3 days of treatment.
  • the hives have lasted more than 6 weeks.

If pregnant or breast-feeding:
  • If breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

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
  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

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

Questions?

call 1-855-274-4122

Keep the carton. It contains important information.


Manufactured for:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

M.L.No.: 19/HD/AP/95/F/R

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


AUROHEALTH
Original Prescription Strength                 NDC 58602-446-09
Cetirizine
Hydrochloride
Tablets USP 5 mg
Antihistamine  HIVES Relief

24 hour                                         
Relief of Itching                          
Due to Hives                                

30
Tablets
5 mg each



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

AUROHEALTH
NDC 58602-446-21
Original Prescription Strength 
Cetirizine
Hydrochloride
Tablets USP
5 mg
Antihistamine  
HIVES Relief

24 hour
Relief of Itching Due to Hives                          

100 (10 x 10) Unit-dose Tablets


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

AUROHEALTH
Original Prescription Strength                 
NDC 58602-447-09
Cetirizine
Hydrochloride
Tablets USP 10 mg
Antihistamine
6 yrs & older
HIVES Relief
24 hour
Relief of itching                             
Due to Hives

30
Tablets
10 mg each




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

AUROHEALTH
NDC 58602-447-21
Original Prescription Strength
Cetirizine
Hydrochloride
Tablets USP
10 mg
Antihistamine
6 yrs & older                                
HIVES Relief

24 hour
Relief of Itching Due to Hives              
100 (10 x 10) Unit-dose Tablets




CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-446
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2910 (5 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeX;35
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-446-091 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:58602-446-171 BOTTLE in 1 CARTON
245 TABLET in 1 BOTTLE
3NDC:58602-446-4775 TABLET in 1 PACKAGE, COMBINATION
4NDC:58602-446-411000 TABLET in 1 BOTTLE
5NDC:58602-446-2110 BLISTER PACK in 1 CARTON
510 TABLET in 1 BLISTER PACK
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2910 (5 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint CodeX;36
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-447-091 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:58602-447-171 BOTTLE in 1 CARTON
245 TABLET in 1 BOTTLE
3NDC:58602-447-4775 TABLET in 1 PACKAGE, COMBINATION
4NDC:58602-447-411000 TABLET in 1 BOTTLE
5NDC:58602-447-2110 BLISTER PACK in 1 CARTON
510 TABLET in 1 BLISTER PACK
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2910 (5 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White to Off-white) Score2 pieces
ShapeRECTANGLE (off-rectangular) Size9mm
FlavorImprint CodeX;2;0
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-813-091 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:58602-813-171 BOTTLE in 1 CARTON
245 TABLET in 1 BOTTLE
3NDC:58602-813-9975 TABLET in 1 PACKAGE, COMBINATION
4NDC:58602-813-231 BOTTLE in 1 CARTON
4120 TABLET in 1 BOTTLE
5NDC:58602-813-391 BOTTLE in 1 CARTON
5365 TABLET in 1 BOTTLE
6NDC:58602-813-411000 TABLET in 1 BOTTLE
7NDC:58602-813-0410 TABLET in 1 CARTON
8NDC:58602-813-8310 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917642ANALYSIS(58602-446, 58602-447, 58602-813), MANUFACTURE(58602-446, 58602-447, 58602-813)

 
Aurohealth LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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