Label: PREVACID 24 HR- lansoprazole capsule, delayed release

  • NDC Code(s): 0067-6286-14, 0067-6286-28, 0067-6286-29, 0067-6286-42
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 26, 2016

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

  • Active ingredient (in each capsule)

    Lansoprazole 15 mg

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  • Purpose

    Acid Reducer

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  • 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

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  • Warnings

    Allergy alert: Do not use if you are allergic to lansoprazole

    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

    liver disease
    had heartburn over 3 months. This may be a sign of a more serious condition.
    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 lose
    nausea or vomiting
    stomach pain

    Ask a doctor or pharmacist before use if you are taking

    warfarin (blood-thinning medicine)
    prescription antifungal or anti-yeast medicines
    digoxin (heart medicine)
    theophylline (asthma medicine)
    tacrolimus or mycophenolate mofetil (immune system medicines)
    atazanavir (medicine for HIV infection)
    methotrexate (arthritis medication)

    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.

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  • Directions

    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, although 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
    swallow whole. Do not crush or chew capsules
    do not use for more than 14 days unless directed by your doctor

    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 before use. Heartburn in children may sometimes be caused by a serious condition.
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  • Other information

    read the directions, warnings and package insert before use
    keep the carton and package insert. They contain important information.
    store at 20-25°C (68-77°F)
    keep product out of high heat and humidity
    protect product from moisture
    close cap tightly after use
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  • Inactive ingredients

    colloidal silicon dioxide, D&C red No. 28, FD&C blue No. 1, FD&C Green No. 3, FD&C red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacryclic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

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  • Questions or comments?

    1-800-452-0051

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  • Principal Display Panel

    NDC 0067-6286-14

    PREVACID®

    24HR

    Lansoprazole delayed-release capsules 15 mg / acid reducer

    SAVE ON YOUR NEXT PURCHASE!

    LOOK FOR YOUR COUPON INSIDE.

    May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
    Clinically Proven To Treat Frequent Heartburn

    14 CAPSULES

    ONE 14-DAY COURSE OF TREATMENT

    Sodium Free

    Visit us at www.prevacid24hr.com

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks are owned by or license to the GSK group of companies

    ©2015 GSK group of companies or its licensor. All rights reserved

    PREVACID® is a registered trademark of Takeda Pharmaceuticals North American, Inc., and is used under license

    46165789

    Prevacid 14 count carton
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  • INGREDIENTS AND APPEARANCE
    PREVACID  24 HR
    lansoprazole capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6286
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE (Teal) , PINK Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code P24HR
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6286-14 1 in 1 CARTON 10/12/2009
    1 14 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0067-6286-28 2 in 1 PACKAGE, COMBINATION 10/12/2009
    2 14 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0067-6286-42 3 in 1 PACKAGE, COMBINATION 10/12/2009
    3 14 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0067-6286-29 3 in 1 PACKAGE, COMBINATION 10/12/2009
    4 14 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022327 10/12/2009
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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