Label: LANSOPRAZOLE- lansoprazole capsule, delayed release 

  • Label RSS
  • NDC Code(s): 42507-117-01, 42507-117-03
  • Packager: HyVee Inc
  • 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 03/14

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.
    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 (blood-thinning medicine)
    prescription antifungal or anti-yeast medicines
    digoxin (heart medicine)
    theophylline (asthma medicine)
    tacrolimus (immune system medicine)
    atazanavir (medicine for HIV infection)

    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. (1-800-222-1222)

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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.

    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
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  • Inactive ingredients

    D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

    Questions or comments?

    1-800-719-9260

    Consumer Information

    Lansoprazole Delayed-Release Capsules 15 mg

    Acid Reducer

    May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

    Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg.

    Save for future reference.

    How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn

    Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

    What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg

    Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.

    Who Should Take Lansoprazole Delayed-Release Capsules 15 mg

    Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

    Who Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg

    People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

    How to Take Lansoprazole Delayed-Release Capsules 15 mg

    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.

    When to Take Lansoprazole Delayed-Release Capsules 15 mg Again

    You may repeat a 14-day course of therapy every 4 months.

    When to Talk to Your Doctor

    Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

    Warnings and When to Ask Your Doctor

    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

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

    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. (1-800-222-1222)

    Tips for Managing Heartburn

    Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
    Eat slowly and do not eat big meals.
    Do not eat late at night or just before bedtime.
    Do not lie flat or bend over soon after eating.
    Raise the head of your bed.
    Wear loose-fitting clothing around your stomach.
    If you are overweight, lose weight.
    If you smoke, quit smoking.

    Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn

    In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

    How Lansoprazole Delayed-Release Capsules 15 mg is Sold

    Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

    For Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg

    Call 1-800-719-9260

    Distributed by:

    Perrigo.jpg

    Allegan, MI 49010

    : 3T300 00 J3

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  • Package/Label Principal Display Panel

    Compare to Prevacid® 24 HR active ingredient

    24 HR

    Lansoprazole

    delayed-release capsules 15 mg / acid reducer

    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

    Actual Size

    14 CAPSULES

    One 14-day course of treatment

    Sodium Free

    Hy Vee Lansoprazole 1.jpg
    Hy Vee Lansoprazole 2.jpg
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  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-117
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 28  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    GELATIN  
    HYPROMELLOSES  
    MANNITOL  
    MEGLUMINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color PINK, GREEN Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code L3T3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-117-03 3 in 1 CARTON
    1 14 in 1 BOTTLE
    2 NDC:42507-117-01 1 in 1 CARTON
    2 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202319 05/21/2012
    Labeler - HyVee Inc (006925671)
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