Cetirizine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetirizine Hydrochloride

Torrent Pharmaceuticals Limited

Cetirizine Hydrochloride Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts:

Active ingredient (in each tablet)

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:

  • 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
  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

Cetirizine Hydrochloride

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL

NDC 13668-030-04

Cetirizine HCl Tablets 10 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

500 Tablets 10 mg each

Tamper Evident:

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

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13668-030
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 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 Size Imprint Code Shape
WHITE (white to off-white) 9 mm 10;30 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13668-030-06 30 in 1 BOTTLE
2 NDC:13668-030-02 100 in 1 BOTTLE
3 NDC:13668-030-03 250 in 1 BOTTLE
4 NDC:13668-030-04 500 in 1 BOTTLE

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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