PRILOSEC OTC - omeprazole magnesium tablet, delayed release 
Physicians Total Care, Inc.

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Prilosec
OTC®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer

Drug Facts

Active ingredient (in each tablet)

Omeprazole magnesium delayed-release tablet 20.6 mg (equivalent to 20 mg omeprazole).

Purpose

Acid reducer

Use

Warnings

Allergy alert

Do not use if you are allergic to omeprazole

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

  • had heartburn over 3 months.
    This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are taking

  • warfarin, clopidogrel, or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
  • you need to take more than 1 course of treatment every 4 months

If pregnant or breast-feeding, 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

Other information

Inactive ingredients

glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

1-800-289-9181

Dist. by Procter & Gamble, Cincinnati, OH 45202

Product of Sweden



Relabeling "Additional Bar Code Label" by:
Physicians Total Care, Inc.
Tulsa, OK       74146

PRINCIPAL DISPLAY PANEL

NDC 54868-5309-0

Prilosec
OTC
®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer

42 TABLETS

Treats FREQUENT Heartburn!
Occurring
2 Or More Days A Week

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton
PRILOSEC OTC 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5309(NDC:37000-455)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
omeprazole magnesium (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole magnesium20.6 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize15mm
FlavorImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5309-03 in 1 CARTON
11 in 1 CARTON
114 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02122905/23/2005
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 6/2011
Document Id: 3ab3af08-bbd8-4fe4-ba32-971374fe2b30
Set id: 6ceb26ec-7ae4-45d5-96d1-82439273613b
Version: 1
Effective Time: 20110620
 
Physicians Total Care, Inc.