CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)- cetirizine hydrochloride tablet

Cetirizine Hydrochloride (Hives Relief) by

Drug Labeling and Warnings

Cetirizine Hydrochloride (Hives Relief) by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-446
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	X;35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-446-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-446-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-446-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-446-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
5	NDC: 58602-446-21	10 in 1 CARTON	08/05/2015
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-447
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-447-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-447-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-447-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-447-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
5	NDC: 58602-447-21	10 in 1 CARTON	08/05/2015
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-813
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to Off-white)	Score	2 pieces
Shape	RECTANGLE (off-rectangular)	Size	9mm
Flavor		Imprint Code	X;2;0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-813-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-813-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-813-99	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-813-23	1 in 1 CARTON	08/05/2015
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-813-39	1 in 1 CARTON	08/05/2015
5		365 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-813-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
7	NDC: 58602-813-04	10 in 1 CARTON; Type 0: Not a Combination Product	08/05/2015
8	NDC: 58602-813-83	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)