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

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Cetirizine Hydrochloride

Mylan Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)

Cetirizine hydrochloride USP, 5 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

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

Cetirizine Hydrochloride Other information

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

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

PRINCIPAL DISPLAY PANEL - 5 mg Allergy

NDC 0378-3635-01

Cetirizine HCl
Tablets
Allergy
5 mg
Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

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

RM-AR3635A3      100 Tablets

Tamper Evident: do not use if foil seal
under cap is missing, open or broken.

PRINCIPAL DISPLAY PANEL - 10 mg Allergy

NDC 0378-3637-01

Cetirizine HCl
Tablets
Allergy
10 mg
Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

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

RM-AR3637A3      100 Tablets     

Tamper Evident: do not use if foil seal
under cap is missing, open or broken.

Active Ingredient (in each tablet)
Cetirizine hydrochloride USP, 10 mg

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

Cetirizine Hydrochloride

cetirizine hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0378-3635
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm M;C35 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0378-3635-01 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076677 2007-12-27


Cetirizine Hydrochloride

cetirizine hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0378-3637
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm M;C37 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0378-3637-01 100 in 1 BOTTLE, PLASTIC
2 NDC:0378-3637-05 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076677 2007-12-27


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