Label: OMEPRAZOLE MAGNESIUM capsule, delayed release

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

Drug Label Information

Updated December 7, 2017

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

  • Active ingredient (in each capsule)

    *Omeprazole delayed-release capsules 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:

    • 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 capsule with a glass of water before eating in the morning
      • take every day for 14 days 
      • do not take more than 1 capsule a day
      • do not use for more than 14 days unless directed by your doctor
      • swallow whole. Do not chew or crush capsules.

        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

    black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions

    call 1-888-375-3784

  • 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

  • Omeprazole Delayed-Release Capsules, 20 mg*, 42-count - Carton Label

    Compare to the active
    ingredient in Prilosec OTC®**

    NDC 37808-006-33

    H-E-B®

    OMEPRAZOLE
    Delayed-release Capsules 20 mg*

    Acid Reducer

    Treats Frequent Heartburn!

    14 CAPSULES
    One 14-Day Course of Treatment

    May take 1 to 4 days for full effect

    Carton

  • Omeprazole Delayed-Release Capsules, 20 mg*, 14-count - Bottle Label

    NDC 37808-006-52

    H-E-B®

    OMEPRAZOLE
    Delayed-release Capsules 20 mg*

    Acid Reducer

    Treats Frequent Heartburn!  

    14 CAPSULES 
    One 14-Day Course of Treatment

    May take 1 to 4 days for full effect

    Bottle

  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE MAGNESIUM 
    omeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-006(NDC:55111-397)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Gelatin (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)  
    Magnesium Oxide (UNII: 3A3U0GI71G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
    Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITE, PINKScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code OMP20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-006-521 in 1 CARTON01/01/2016
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:37808-006-333 in 1 CARTON01/01/2016
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07887801/01/2016
    Labeler - HEB (007924756)