CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL ER- cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release 
Physicians Total Care, Inc.

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Drug Facts

Active Ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • 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

  • do not use more than directed
  • 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.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

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 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and overask a doctor
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.

Questions or comments?

1-800-525-8747

Sandoz Inc.

Princeton, NJ 08540

05-2010M



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

HOW SUPPLIED:


30 Tablets, Bottles              NDC 54868-5884-1

60 Tablets, Bottles              NDC 54868-5884-0

24 Tablets, Blister Pack      NDC 54868-5884-2

5 mg/120 mg Label

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion

Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Label

CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL  ER
cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5884(NDC:0781-5285)
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2208 (15000 CPS) (UNII: Z78RG6M2N2)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize10mm
FlavorImprint Code SZ912
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5884-24 in 1 CARTON
16 in 1 BLISTER PACK
2NDC:54868-5884-130 in 1 BOTTLE
3NDC:54868-5884-060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07799103/31/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 6/2010
Document Id: 6f6eac97-fbc3-44a5-a6f4-fba3e559f664
Set id: c8b28b1a-d7de-42d0-96bf-a1e04253892f
Version: 2
Effective Time: 20100607
 
Physicians Total Care, Inc.