Label: LANSOPRAZOLE tablet, orally disintegrating, delayed release

  • NDC Code(s): 0363-1419-55, 0363-1419-74
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 27, 2018

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

  • Active ingredient (in each tablet)

    Lansoprazole 15mg

  • 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

    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 medicine)
  • 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 (1-800-222-1222).

  • 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

    take 1 tablet before eating in the morning
    do not crush or chew tablets
    place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
    take every day for 14 days
    do not take more than 1 tablet a day
    do not use for more than 14 days unless directed by your doctor
    do not take this medicine with alcohol

    Repeated 14-Day Course (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
  • Inactive ingredients

    ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

    Consumer Information

    Treats Frequent Heartburn

    Lansoprazole

    Delayed Release

    Orally Disintegrating Tablets 15 mg

    acid reducer

    • May take 1 to 4 days for full effect

    Please read the entire package insert before taking

    Lansoprazole Delayed Release Orally Disintegrating Tablets.

    Save for future reference.

    How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent Heartburn

    Lansoprazole delayed release orally disintegrating tablets stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once a day (every 24 hours), every day for 14 days.

    What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tablets

    Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole 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 orally disintegrating tablets every day for 14 days to treat your frequent heartburn.

    Who Should Take Lansoprazole delayed release orally disintegrating tablets

    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 orally disintegrating tablets

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

    How to Take Lansoprazole delayed release orally disintegrating tablets

    14-DAY Course of Treatment

    Take 1 tablet before eating in the morning.
    Do not crush or chew tablets.
    Place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
    Take every day for 14 days.
    Do not take more than 1 tablet a day.
    Do not use for more than 14 days unless directed by your doctor.
    Do not take this medicine with alcohol.

    When to Take Lansoprazole delayed release orally disintegrating tablets 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 or mycophenolate mofetil (immune system medicines)
    atazanavir (medicine for HIV infection)
    methotrexate (arthritis medicine)

    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 (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 that lansoprazole effectively treats frequent heartburn

    In three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.

    How Lansoprazole delayed release orally disintegrating tablets is Sold

    This medicine is available in 14 tablet, 28 tablet and 42 tablet 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 orally disintegrating tablets

    Call 1-800-719-9260

    weekdays 7:30 AM to 5:00 PM EST

    Made in Israel

    Manufactured by:

    Dexcel Pharma Technologies Ltd.

    10 Hakidma Street, Yokneam 2069200, Israel

    :8U100 00 J2

    1249460078-A

    OR

    :8U174 00 J2

  • Package/Label Principal Display Panel

    MELTech™

    Melts In Your Mouth

    Treats Frequent Heartburn

    Compare to Prevacid® 24 HR active ingredient

    Lansoprazole

    DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg / ACID REDUCER

    MELTS IN YOUR MOUTH; DISSOLVES WITHOUT WATER

    ORALLY DISINTEGRATING TABLETS

    24 HOUR

    May take 1 to 4 days for full effect

    ACTUAL SIZE

    42 TABLETS

    THREE 14-DAY COURSES OF TREATMENT

    STRAWBERRY FLAVOR

    Lansoprazole Carton Image 1
    Lansoprazole Carton Image 2
  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole tablet, orally disintegrating, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1419
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTITOL (UNII: D65DG142WK)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (off white mottled) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1419-553 in 1 CARTON05/25/2017
    114 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-1419-741 in 1 CARTON05/25/2017
    214 in 1 CARTON
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20802505/25/2017
    Labeler - Walgreen Company (008965063)