Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 20, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

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

  • Purpose

    Acid reducer

  • Use

    • treats frequent heartburn (occurs 2 or more days a week)
    • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
  • 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

    • for adults 18 years of age and older
    • this product is to be used once a day (every 24 hours), every day for 14 days
    • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
      14-Day Course of Treatment
      • swallow 1 tablet with a glass of water before eating in the morning
      • take every day for 14 days
      • do not take more than 1 tablet a day
      • do not use for more than 14 days unless directed by your doctor
      • swallow whole. Do not chew or crush tablets.
      Repeated 14-Day Courses (if needed)
      • you may repeat a 14-day course every 4 months
      • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
    • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
  • Other information

    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • store at 20-25°C (68-77°F) and protect from moisture
  • 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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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
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