CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated 
Physicians Total Care, Inc.

----------

Drug Facts

Active ingredient

Cetirizine Hydrochloride 5 mg

Purpose

Antihistamine

Uses

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

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

Other information

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

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

 PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

NDC 54868-5855-0

Cetirizine Hydrochloride
Tablets 5 mg
antihistamine

24
HOUR

Relief of
ITCHING
Due to Hives

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

Cetirizine Hydrochloride Tablets 5 mg package label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5855(NDC:0378-3635)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code M;C35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5855-0100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667701/29/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: 6ffa08b1-f48a-45b8-95ce-9ed2672c4902
Set id: 3f3576ca-8ed0-4f0e-bcf8-38dabb3bd1fe
Version: 1
Effective Time: 20120521
 
Physicians Total Care, Inc.