Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release

  • NDC Code(s): 84126-300-14, 84126-300-24, 84126-300-42, 84126-300-56
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 29, 2026

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 moredays 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.
    • Omeprazole may cause severe skin reactions. Symptoms may include:
      • skin reddening • blisters • rash
    If an allergic reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    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 a prescription drug.
    Acid reducers may interact with certain prescription drugs.

  • 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
    • you develop a rash or joint pain
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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 to 25°C (68 to 77°F) and protect from moisture
  • Inactive ingredients

    acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type c, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, red iron oxide, sucrose, talc, titanium dioxide, triethyl citrate

  • Questions?

    1-800-289-9181

  • SPL UNCLASSIFIED SECTION

    Safety Feature - Do not use if tablet blister unit is open or torn.

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 42 Tablet Carton

    NEW FORMULA

    SAME ACTIVE INGREDIENT.

    SEE CURRENT DRUG FACTS.

    NDC 84126-300-42

    Treats FREQUENT Heartburn! 24 HR

    Prilosec OTC ®


    omeprazole delayed-release tablets

    20 mg / acid reducer

    Three 14-day courses of treatment

    May take 1 to 4 days for full effect.

    42 TABLETS

    300

  • INGREDIENTS AND APPEARANCE
    PRILOSEC OTC 
    omeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL TRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL 8000000 (UNII: 8EIY1IHX76)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeOVALSize13mm
    FlavorImprint Code 24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-300-141 in 1 CARTON09/01/2025
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:84126-300-423 in 1 CARTON09/01/2025
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:84126-300-242 in 1 CARTON09/01/2025
    314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:84126-300-564 in 1 CARTON07/29/2026
    414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20658209/01/2025
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Registrant - The Procter & Gamble Manufacturing Company (004238200)