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Omeprazole Magnesium (Dr. Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
CAPSULE, DELAYED RELEASE 2 CARTON in 1 CARTON (55111-397-28) > 2 BLISTER PACK in 1 CARTON (55111-397-74) > 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK Label Information
CAPSULE, DELAYED RELEASE 2 CARTON in 1 CARTON (55111-397-28) > 2 BLISTER PACK in 1 CARTON (55111-397-74) > 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK Label Information
CAPSULE, DELAYED RELEASE 2 BOTTLE in 1 CARTON (55111-397-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 2 BOTTLE in 1 CARTON (55111-397-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 3 CARTON in 1 CARTON (55111-397-42) > 2 BLISTER PACK in 1 CARTON (55111-397-74) > 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK Label Information
CAPSULE, DELAYED RELEASE 3 CARTON in 1 CARTON (55111-397-42) > 2 BLISTER PACK in 1 CARTON (55111-397-74) > 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK Label Information
CAPSULE, DELAYED RELEASE 1500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-397-89) Label Information
CAPSULE, DELAYED RELEASE 1500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-397-89) Label Information
CAPSULE, DELAYED RELEASE 3 BOTTLE in 1 CARTON (55111-397-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 3 BOTTLE in 1 CARTON (55111-397-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 1 BOTTLE in 1 CARTON (55111-397-52) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 1 BOTTLE in 1 CARTON (55111-397-52) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information

Complete Omeprazole Magnesium Information

  • 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 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


  • PRINCIPAL DISPLAY PANEL

    Container Label:

    container


  • PRINCIPAL DISPLAY PANEL

    Container Carton Label

    containercarton


  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE MAGNESIUM 
    omeprazole magnesium capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-397
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    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)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    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)  
    Product Characteristics
    Color WHITE, PINK Score no score
    Shape CAPSULE Size 22mm
    Flavor Imprint Code OMP20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-397-52 1 in 1 CARTON 03/01/2010
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:55111-397-27 2 in 1 CARTON 03/01/2010
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:55111-397-33 3 in 1 CARTON 03/01/2010
    3 14 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:55111-397-39 3 in 1 CARTON 09/01/2015
    4 14 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:55111-397-28 2 in 1 CARTON 03/01/2010
    5 NDC:55111-397-74 2 in 1 CARTON
    5 7 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:55111-397-42 3 in 1 CARTON 03/01/2010
    6 NDC:55111-397-74 2 in 1 CARTON
    6 7 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078878 03/01/2010
    Labeler - Dr. Reddy's Laboratories Limited (650562841)