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

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Cetirizine Hydrochloride

Caraco Pharmaceutical Laboratories, Ltd.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 10 mg

Purpose

Antihistamine

Cetirizine Hydrochloride Uses

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

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

  • 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.

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 corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide

Questions or comments?

call toll free 1-800-818-4555 weekdays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

NDC  57664-540-83

Cetirizine Hydrochloride Tablets,  5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.


Cetirizine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

NDC  57664-540-83

Cetirizine Hydrochloride Tablets, 5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.


Cetirizine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

NDC  57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

Cetirizine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

NDC  57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.


Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57664-540
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
cellulose, microcrystalline
STARCH, CORN
povidone
MAGNESIUM STEARATE
hypromellose
polyethylene glycol
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white) 7 mm 540;C ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57664-540-83 30 in 1 BOTTLE
2 NDC:57664-540-88 100 in 1 BOTTLE
3 NDC:57664-540-26 500 in 1 BOTTLE
4 NDC:57664-540-27 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077499 2007-12-27


Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57664-541
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
cellulose, microcrystalline
STARCH, CORN
povidone
MAGNESIUM STEARATE
hypromellose
polyethylene glycol
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white) 9 mm 541;C ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57664-541-83 30 in 1 BOTTLE
2 NDC:57664-541-88 100 in 1 BOTTLE
3 NDC:57664-541-26 500 in 1 BOTTLE
4 NDC:57664-541-27 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077499 2007-12-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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