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

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Cetirizine Hydrochloride

REMEDYREPACK INC.

Cetirizine Hydrochloride Tablets, 10 mg, Allergy


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT

Active Ingredients (in each tablet)                                                        Purpose

Cetirizine HCl 10 mg..............................................................................................Antihistimine

 

OTC - PURPOSE

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.

 

OTC - ASK DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

 

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

 

OTC - WHEN USING

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

 

OTC - STOP USE

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

 

OTC - PREGNANCY OR BREAST FEEDING

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

 

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact Poison Control Center right away.

 

DOSAGE & ADMINISTRATION

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 sever 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

 

SPL UNCLASSIFIED

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

 

INACTIVE INGREDIENT

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

 

OTC - QUESTIONS

Call 1-866-562-4597

 

SPL UNCLASSIFIED

Manufactured for PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Cetirizine Hydrochloride


GENERIC: Cetirizine Hydrochloride


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-332-20


ACTIVE INGREDIENT(S):

  • Cetirizine Hydrochloride 10mg in 1


INACTIVE INGREDIENT(S):

  • hypromelloses
  • polyethylene glycol
  • povidone
  • starch, corn
  • lactose
  • magnesium stearate
  • titanium dioxide


COLOR: white


SHAPE: BULLET


SCORE: No score


SIZE: 8 mm


IMPRINT: CTN;10


PACKAGING: 100 in 1 VIAL



Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-332(NDC:16571-402)
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
HYPROMELLOSES
POLYETHYLENE GLYCOLS
povidone
STARCH, CORN
LACTOSE
MAGNESIUM STEARATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 8 mm CTN;10 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-332-20 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077829 2013-06-10


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