Prevent an allergic reaction from happening at school.

Cetirizine Tablets

Pronunciation

Generic Name: cetirizine hydrochloride
Dosage Form: tablet

Cetirizine Hydrochloride Tablets

Drug Facts:

Active ingredient (in each tablet)  

Cetirizine HCl 5 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:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • trouble speaking
  • swelling in or around mouth
  • 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 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

  • 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.

Directions

  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

Other information

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• 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

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL

NDC 13668-029-04

Cetirizine HCl Tablets 5 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

500 Tablets 5 mg each

Tamper Evident:

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

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:13668-029-06 30 TABLET (30 TABLET) in 1 BOTTLE
2 NDC:13668-029-02 100 TABLET (100 TABLET) in 1 BOTTLE
3 NDC:13668-029-03 250 TABLET (250 TABLET) in 1 BOTTLE
4 NDC:13668-029-04 500 TABLET (500 TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079191 04/15/2010
Labeler - Torrent Pharmaceuticals Limited (916488547)
Revised: 07/2010
 
Torrent Pharmaceuticals Limited



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