Cetirizine Hydrochloride Tablets 5 mg

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Kaiser Foundation Hospitals, Unique Pharmaceutical Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Kaiser Foundation Hospitals

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Cetirizine Hydrochloride Tablets 5 mg

NDC: 00179-8302-01
Original Prescription Strength

Container Label

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

Container Label

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

Container Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0179-8302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0179-8302-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/13/201311/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782912/13/201311/30/2019
Labeler - Kaiser Foundation Hospitals (053052619)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(0179-8302)

Revised: 11/2018
Document Id: 7b09840f-5839-588a-e053-2a91aa0ad033
Set id: 2e88539e-c12a-4e2d-b945-2942dfb0f07c
Version: 2
Effective Time: 20181119
 
Kaiser Foundation Hospitals