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 Type HUMAN OTC DRUG NDC Product Code (Source) 29300-133
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL 400  
POVIDONE K29/32  
STARCH, CORN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape RECTANGLE (Rounded-off) Size 7mm
Flavor Imprint Code U;133
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 29300-133-13 1 BOTTLE In 1 CARTON contains a BOTTLE
1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-133-13)
2 29300-133-45 1 BOTTLE In 1 CARTON contains a BOTTLE
2 45 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-133-45)
3 29300-133-75 1 BOTTLE In 1 CARTON contains a BOTTLE
3 75 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-133-75)
4 29300-133-19 1 BOTTLE In 1 CARTON contains a BOTTLE
4 90 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-133-19)
5 29300-133-01 1 BOTTLE In 1 CARTON contains a BOTTLE
5 100 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-133-01)
6 29300-133-00 200000 TABLET In 1 DRUM None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078680 11/30/2010

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 29300-134
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL 400  
POVIDONE K29/32  
STARCH, CORN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape RECTANGLE (Rounded-off) Size 9mm
Flavor Imprint Code U;134
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 29300-134-13 1 BOTTLE In 1 CARTON contains a BOTTLE
1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-134-13)
2 29300-134-45 1 BOTTLE In 1 CARTON contains a BOTTLE
2 45 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-134-45)
3 29300-134-75 1 BOTTLE In 1 CARTON contains a BOTTLE
3 75 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-134-75)
4 29300-134-19 1 BOTTLE In 1 CARTON contains a BOTTLE
4 90 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-134-19)
5 29300-134-01 1 BOTTLE In 1 CARTON contains a BOTTLE
5 100 TABLET In 1 BOTTLE This package is contained within the CARTON (29300-134-01)
6 29300-134-00 100000 TABLET In 1 DRUM None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078680 11/30/2010

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