CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Torrent Pharmaceuticals Limited

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Cetirizine Hydrochloride

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

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Image

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL – 5 mg Allergy

NDC 13668-029-30

Cetirizine HCl Tablets 5 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

30 Tablets 5 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

Image

PRINCIPAL DISPLAY PANEL – 10 mg Allergy

NDC 13668-030-30

Cetirizine HCl Tablets 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

30 Tablets 10 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

Image

 

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 occuring.

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

•  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

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 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)

Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Image

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

 

NDC 13668-029-30

Cetirizine HCl Tablets 5 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

30 Tablets 5 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

Image

PRINCIPAL DISPLAY PANEL – 10 mg Hives Relief

NDC 13668-030-30

Cetirizine HCl Tablets 10 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

30 Tablets 10 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

Image

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 13668-029
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
COLLOIDAL SILICON DIOXIDE  
STARCH, CORN  
HYPROMELLOSE 2910 (6 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL 400  
POVIDONE K30  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (white to off-White) Score no score
Shape ROUND (rounded-off,rectangular shaped, film coated tablet) Size 7mm
Flavor Imprint Code 5;29
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 13668-029-30 30 TABLET In 1 BOTTLE None
2 13668-029-01 100 TABLET In 1 BOTTLE None
3 13668-029-25 250 TABLET In 1 BOTTLE None
4 13668-029-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079191 04/15/2010

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 13668-030
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
COLLOIDAL SILICON DIOXIDE  
STARCH, CORN  
HYPROMELLOSE 2910 (6 CPS)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL 400  
POVIDONE K30  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (rounded-off,rectangular shaped, film coated tablet) Size 9mm
Flavor Imprint Code 10;30
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 13668-030-30 30 TABLET In 1 BOTTLE None
2 13668-030-01 100 TABLET In 1 BOTTLE None
3 13668-030-25 250 TABLET In 1 BOTTLE None
4 13668-030-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079191 04/15/2010

Labeler - Torrent Pharmaceuticals Limited (650175722)
Revised: 04/2010 Torrent Pharmaceuticals Limited