Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release

  • NDC Code(s): 37000-455-01, 37000-455-02, 37000-455-03, 37000-455-04, view more
    37000-455-05
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 5, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

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

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  • Purpose

    Acid reducer

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  • 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
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  • 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
    • 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


    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.
    • 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 or mycophenolate mofetil (immune system medicines)
    • prescription antiretrovirals (medicines for HIV infection)
    • methotrexate (arthritis medicine)

    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
    • you get diarrhea

    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.

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  • 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.
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  • 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
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  • 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

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  • Questions?

    1-800-289-9181

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

    Product of Sweden

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  • PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

    NDC 37000-455-02

    Prilosec

    OTC
    ®

    omeprazole delayed-release tablets

    20 mg / acid reducer

    14 TABLETS
    One 14-day course of treatment

    Treats FREQUENT Heartburn!
    Occurring
    2 Or More Days A Week

    455 Prilosec Regular

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  • INGREDIENTS AND APPEARANCE
    PRILOSEC OTC 
    omeprazole magnesium tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-455
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code P
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-455-01 1 in 1 POUCH; Type 0: Not a Combination Product 07/14/2003
    2 NDC:37000-455-02 1 in 1 CARTON 07/14/2003
    2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:37000-455-03 2 in 1 CARTON 07/14/2003
    3 1 in 1 CARTON
    3 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:37000-455-04 3 in 1 CARTON 07/14/2003
    4 1 in 1 CARTON
    4 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:37000-455-05 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/14/2003
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021229 07/14/2003
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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