Label: OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release

  • NDC Code(s): 55111-397-27, 55111-397-28, 55111-397-33, 55111-397-42, view more
    55111-397-52, 55111-397-74
  • Packager: Dr. Reddy's Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • SPL PRODUCT DATA ELEMENTS

    Drug Facts

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  • Active ingredient(s)

    Omeprazole magnesium delayed-release capsule 20.6 mg

    (equivalent to 20 mg omeprazole)

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  • Purpose

    Acid reducer

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  • Use(s)

    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

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  • 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.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.

    • 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

    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 (immune system medicine)

    • prescription antiretrovirals (medicines for HIV infection) 

    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

     

    Pregnancy/Breastfeeding

    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.

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  • 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.

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  • Other information

    read the directions and warnings before use 

    • keep the carton. It contains important information 

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  • Storage

    • store at 20° – 25°C (68° – 77° F) and protect from moisture

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  • 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, potasium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

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  • Questions

    Call 1-888-375-3784

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    Omeprazole Magnesium Delayed-Release Capsules, 20. 6 mg - Container Label:

    container

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  • PRINCIPAL DISPLAY PANEL

    Omeprazole Magnesium Delayed-Release Capsules, 20.6 mg - Container Carton Label

    containercarton

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  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE MAGNESIUM 
    omeprazole magnesium capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55111-397
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEPRAZOLE MAGNESIUM (omeprazole) omeprazole 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
    GELATIN  
    GLYCERYL MONOSTEARATE  
    HYPROMELLOSE 2208 (3 MPA.S)  
    MAGNESIUM OXIDE  
    MAGNESIUM STEARATE  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    POTASSIUM HYDROXIDE  
    PROPYLENE GLYCOL  
    FERRIC OXIDE RED  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    RAW SUGAR  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    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:55111-397-28 2 in 1 CARTON
    1 NDC:55111-397-74 2 in 1 CARTON
    1 7 in 1 BLISTER PACK
    2 NDC:55111-397-42 3 in 1 CARTON
    2 NDC:55111-397-74 2 in 1 CARTON
    2 7 in 1 BLISTER PACK
    3 NDC:55111-397-52 1 in 1 CARTON
    3 14 in 1 BOTTLE
    4 NDC:55111-397-27 2 in 1 CARTON
    4 14 in 1 BOTTLE
    5 NDC:55111-397-33 3 in 1 CARTON
    5 14 in 1 BOTTLE
    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)
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