Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release

  • NDC Code(s): 37000-459-01, 37000-459-02, 37000-459-03, 37000-459-04, view more
    37000-459-05
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 16, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

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

  • 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
    • heartburn with lightheadedness, sweating or dizziness
    • chest pain or shoulderpain with shortnessof 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.

  • 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, crush, or suck 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

    FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, 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

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

    Treats FREQUENT Heartburn!

    Occurring 2 Or More Days A Week

    NDC 37000-459-02

    Prilosec OTC ®

    omeprazole delayed-release tablets

    20 mg / acid reducer

    SWALLOW - DO NOT CHEW

    14 TABLETS

    One 14-day course of treatment

    Coated with

    Wildberry Flavor

    459 Prilosec Wild Berry

  • INGREDIENTS AND APPEARANCE
    PRILOSEC OTC 
    omeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-459
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICA (UNII: V8A1AW0880)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize15mm
    FlavorBERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-459-011 in 1 POUCH; Type 0: Not a Combination Product08/15/2012
    2NDC:37000-459-0214 in 1 CARTON08/15/2012
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:37000-459-032 in 1 CARTON08/15/201212/01/2022
    314 in 1 CARTON
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:37000-459-043 in 1 CARTON08/15/2012
    414 in 1 CARTON
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:37000-459-051 in 1 BLISTER PACK; Type 0: Not a Combination Product08/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02122908/15/2012
    Labeler - The Procter & Gamble Manufacturing Company (004238200)