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 August 7, 2019

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

  • Active ingredient (in each capsule)

    Lansoprazole 15 mg

  • 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 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.
    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 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 care 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

    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.
  • 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
  • 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

  • Questions or comments?

    1-855-328-5199

  • Principal Display Panel

    NDC 0067-6286-42

    Treats Frequent Heartburn

    PREVACID 24HR

    Lansoprazole delayed-release capsules 15 mg / acid reducer

    May take 1 to 4 days for full effect
    Sodium Free

    42 CAPSULES

    THREE 14-DAY COURSES OF TREATMENT

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2019 GSK group of companies or its licensor.

    KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

    TAMPER-EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

    62000000031308

    62000000031308_Prevacid 24HR_Capsules_42CT.JPG
  • INGREDIENTS AND APPEARANCE
    PREVACID  24 HR
    lansoprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6286
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Teal) , PINKScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code P24HR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6286-141 in 1 CARTON10/12/2009
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-6286-282 in 1 PACKAGE, COMBINATION10/12/2009
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-6286-423 in 1 PACKAGE, COMBINATION10/12/2009
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-6286-293 in 1 PACKAGE, COMBINATION10/12/200905/03/2019
    414 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02232710/12/2009
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)