Cetirizine Hydrochloride Tablets

CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Unichem Pharmaceuticals (USA), Inc.

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Cetirizine Hydrochloride Tablets

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

For 5 mg

Cetirizine HCl 5 mg

For 10 mg

Cetirizine HCl 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.

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 INGREDIENT

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide

QUESTIONS?

call 1-866-562-4616

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Marketed by:

Company Logo

Rochelle Park, NJ 07662.

PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Tablets 5 mg - Allergy

Cetirizine Hydrochloride Tablets 5 mg - Allergy

Cetirizine Hydrochloride Tablets 10 mg - Allergy

Cetirizine Hydrochloride Tablets 10 mg - Allergy

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

For 5 mg

Cetirizine HCl 5 mg

For 10 mg

Cetirizine HCl 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:

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:

because this product will not stop hives from occuring. 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

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.

DIRECTIONS

For 5 mg

adults and children 6 years 
1 to 2 tablets once daily depending upon 
and over
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 
ask a doctor
kidney disease

For 10 mg

adults and children 6 years 
one 10 mg tablet once daily; do not take more 
and over
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 
ask a doctor
kidney disease

OTHER INFORMATION

INACTIVE INGREDIENT

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide

QUESTIONS?

call 1-866-562-4616

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Marketed by:

Company Logo

Rochelle Park, NJ 07662.

PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Tablets 5 mg - Hives Relief

Cetirizine Hydrochloride Tablets 5 mg - Hives Relief

Cetirizine Hydrochloride Tablets 10 mg - Hives Relief

Cetirizine Hydrochloride Tablets 10 mg - Hives Relief


CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)29300-133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 CPS) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE K29/32 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeRECTANGLE (Rounded-off) Size7mm
FlavorImprint Code U;133
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
129300-133-131 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-133-13)
229300-133-451 BOTTLE In 1 CARTONcontains a BOTTLE
245 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-133-45)
329300-133-751 BOTTLE In 1 CARTONcontains a BOTTLE
375 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-133-75)
429300-133-191 BOTTLE In 1 CARTONcontains a BOTTLE
490 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-133-19)
529300-133-011 BOTTLE In 1 CARTONcontains a BOTTLE
5100 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-133-01)
629300-133-00200000 TABLET In 1 DRUMNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868011/30/2010

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)29300-134
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 CPS) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE K29/32 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeRECTANGLE (Rounded-off) Size9mm
FlavorImprint Code U;134
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
129300-134-131 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-134-13)
229300-134-451 BOTTLE In 1 CARTONcontains a BOTTLE
245 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-134-45)
329300-134-751 BOTTLE In 1 CARTONcontains a BOTTLE
375 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-134-75)
429300-134-191 BOTTLE In 1 CARTONcontains a BOTTLE
490 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-134-19)
529300-134-011 BOTTLE In 1 CARTONcontains a BOTTLE
5100 TABLET In 1 BOTTLEThis package is contained within the CARTON (29300-134-01)
629300-134-00100000 TABLET In 1 DRUMNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868011/30/2010

Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)
Revised: 09/2010Unichem Pharmaceuticals (USA), Inc.