GOOD SENSE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]

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  • GOOD SENSE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]

GOOD SENSE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]
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NDC 0113-0116-55
Set ID d86585b7-e146-4f04-9016-412b16e06f55
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number NDA208025
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  • 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 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 (1-800-222-1222).

  • 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 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 (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

    :8U17400J3

  • Package/Label Principal Display Panel

    MELTech™

    Melts In Your Mouth

    Treats Frequent Heartburn

    Lansoprazole

    Delayed Release Orally Disintegrating Tablets 15 mg

    Actual Size

    Orally Disintegrating Tablets

    Acid Reducer

    24 HOUR

    Strawberry Flavor

    May take 1 to 4 days for full effect

    Melts in your mouth; Dissolves without water

    Compare to active ingredient of Prevacid® 24 HR

    42 Tablets

    Three 14-Day Courses of Treatment

    lansoprazole image 1
    lansoprazole image 2
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE LANSOPRAZOLE 
    lansoprazole tablet, orally disintegrating, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0116
    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
    FlavorSTRAWBERRYImprint Code 15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0116-553 in 1 CARTON11/28/2017
    114 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20802511/28/2017
    Labeler - L. Perrigo Company (006013346)
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