Label: OMEPRAZOLE- omeprazole magnesium capsule, delayed release

  • NDC Code(s): 0363-6089-01, 0363-6089-03
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 15, 2024

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  • Active ingredient (in each capsule)

    Omeprazole delayed-release capsule 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.
    •
    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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-888-222-1222).

  • 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
    •
    FDA approved dissolution test specifications differ from USP
  • Inactive ingredients

    FD&C yellow #6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Walgreens

    • WALGREENS • PHARMACIST RECOMMENED

    Compare to the active ingredient in Prilosec OTC®

    Mini Capsules

    Omeprazole

    DELAYED-RELEASE CAPSULES 20 mg / ACID REDUCER

    24 Hour

    Treats FREQUENT Heartburn!

    42 MINI CAPSULES

    ACTUAL SIZE

    THREE 14-DAY COURSES OF TREATMENT

    MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

    SEE CURRENT DRUG FACTS

    24s-94-omeprazole-1
    24s-94-omeprazole-2
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole magnesium capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE, ORANGEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 24S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6089-033 in 1 CARTON04/09/2024
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-6089-0114 in 1 BOTTLE; Type 0: Not a Combination Product04/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21609604/09/2024
    Labeler - Walgreen Company (008965063)
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