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:

Cetirizine HCl 5 mg

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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

  • 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.

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.

  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

  • 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 13668-029-05

Cetirizine HCl Tablets 5 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

500 Tablets 5 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:13668-029
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 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 Size Imprint Code Shape
WHITE (white to off-white) 7 mm 5;29 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13668-029-30 30 in 1 BOTTLE
2 NDC:13668-029-01 100 in 1 BOTTLE
3 NDC:13668-029-25 250 in 1 BOTTLE
4 NDC:13668-029-05 500 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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