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Cetirizine Hydrochloride by Kaiser Foundation Hospitals

Medically reviewed on Dec 13, 2017

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 5mg
Labeler: Kaiser Foundation Hospitals
NDC Code: 0179-8302

Cetirizine Hydrochloride Tablets 5 mg

NDC 00179-8302-01
Original Prescription Strength

Cetirizine Hydrochloride
5 mg Tablets

ANTIHISTAMINE / ALLERGY

For indoor & outdoor allergies

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • Itchy throat or Nose

*Compare to Zyrtec®

100 Tablets

Do not use if imprinted foil inner seal on bottle is broken or missing

Drug Facts
Active ingredients
Cetirizine HCl 5 mg
Purpose
Antihistamine

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of 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
  • drowsines 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. (1-800-222-1222)

Directions
Adult and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

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

Inactive Ingredients

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

Questions?

Call 1-866-562-4597

Zyrtec® is registered trademark of McNeil Consumer & Specialty Pharmaceuticals. This product is not manufactured, distributed or marketed by McNeil Consumer & Specialty Pharmaceuticals

Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai-400 030, India.
Distributed by Kaiser Foundation Hospitals, Livermore, CA, 94551-9756.

PRINCIPAL DISPLAY PANEL - 5 mg Container Label Text

Original Prescription Strength NDC 00179-8302-01

Cetirizine Hydrochloride
5 mg Tablets

Antihistamine Allergy
For indoor and outdoor allergies

24 hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

* Compare to Zyrtec®
100 Tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
STARCH, CORN 
POLYETHYLENE GLYCOLS 
POVIDONES 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint CodeCTN;5
Contains    
Packaging
#Item CodePackage Description
1NDC:0179-8302-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782912/13/2013
Labeler - Kaiser Foundation Hospitals (053052619)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIOperations
Unique Pharmaceutical Laboratories650434645MANUFACTURE(0179-8302)

 
Kaiser Foundation Hospitals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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