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

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Cetirizine Hydrochloride

Physicians Total Care, Inc.

Drug Facrts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Using

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 reactions 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

If pregnant or breast-feeding:

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

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

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

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

How Supplied

Cetirizine HCl Tablets, 10 mg antihistamine tablets; supplied in:

bottles of 14
NDC 54868-5845-1
bottles of 30
NDC 54868-5845-2
bottles of 100
NDC 54868-5845-0

Questions?

1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.02/2008



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

Principal Display Panel

Cetirizine HCl Tablets

10 mg

antihistamine

Tablets.

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose
Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-5845(NDC:0781-1684)
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
STARCH, CORN
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
povidone
titanium dioxide
polyethylene glycol

Product Characteristics

Color Size Imprint Code Shape
white (white to off-white) 8 mm SZ;906 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-5845-0 100 in 1 BOTTLE
2 NDC:54868-5845-1 14 in 1 BOTTLE
3 NDC:54868-5845-2 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077946 2008-01-02


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