Label: OMEPRAZOLE- omeprazole magnesium tablet, delayed release

  • NDC Code(s): 59726-297-14, 59726-297-28, 59726-297-42, 59726-737-14, view more
    59726-737-28, 59726-737-42
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 20, 2023

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

  • 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 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 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.

     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 everyday 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° 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

  • Tips for Managing Heartburn

    • Do not lie flat or bend over after eating
    • Do not wear tight-fitting clothing around the stomach
    • Do not eat before bedtime
    • Raise the head of your bed
    • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
    • Eat slowly and avoid big meals
    • If overweight, lose weight
    • Quit smoking
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Prilosec OTC®*

    Omeprazole Delayed-Release Tablets 20 mg 

     ACID REDUCER

    Treats FREQUENT Heartburn 24 Hr

    One-14-Day Course of Treatment

    14 Tablets

    Omeprazole

    Omeprazole Tablets

  • PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Prilosec OTC®*

    Omeprazole Delayed-Release Tablets 20 mg

    ACID REDUCER 

    SWALLOW - DO NOT CHEW

    Treats FREQUENT Heartburn 24 HR

    14 Tablets 

    One-14-Day Course of Treatment

    Coated with Wildberry Flavor

    Omeprazole

    Ompeprazole Wildberry Tablets


  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-297
    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
    ACETYLTRIBUTYL 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)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (capsule-shaped) Size13mm
    FlavorImprint Code OM;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-297-141 in 1 CARTON06/02/202012/31/2025
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59726-297-282 in 1 CARTON06/02/202012/31/2025
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59726-297-423 in 1 CARTON06/02/202012/31/2025
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20658206/02/202012/31/2025
    OMEPRAZOLE 
    omeprazole magnesium tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-737
    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
    ACETYLTRIBUTYL 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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIACETIN (UNII: XHX3C3X673)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize13mm
    FlavorBERRYImprint Code OM;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-737-141 in 1 CARTON06/02/202012/31/2025
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59726-737-282 in 1 CARTON06/02/202012/31/2025
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59726-737-423 in 1 CARTON06/02/202012/31/2025
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20658206/02/202012/31/2025
    Labeler - P & L Development, LLC (800014821)