UP AND UP LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]

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UP AND UP LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]
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NDC 11673-117-01, 11673-117-02, 11673-117-03
Set ID 70bade45-0d35-46db-964e-a8ad9dd91646
Category HUMAN OTC DRUG LABEL
Packager Target Corporation
Generic Name
Product Class
Product Number
Application Number ANDA202319
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  • 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 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

    •
    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

    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?

    Call 1-888-547-7400

    Consumer Information

    Treats Frequent Heartburn

    Lansoprazole

    Delayed-Release Capsules 15 mg / Acid Reducer

    •
    May take 1 to 4 days for full effect
    •
    Sodium Free

    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 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).

    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®

    Allegan, MI 49010

    : 3T300 00 J6

  • Package/Label Principal Display Panel

    Compare to active ingredient in Prevacid® 24 HR

    lansoprazole delayed release capsules, 15 mg

    acid reducer 24-hour

    may take 1 to 4 days for full effect

    sodium free

    treats frequent heartburn

    ACTUAL SIZE

    14 CAPSULES

    14 CAPSULES – ONE 14-DAY COURSE OF TREATMENT

    Lansoprazole Carton Image 1
    Lansoprazole Carton Image 2
  • INGREDIENTS AND APPEARANCE
    UP AND UP LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK, GREENScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code L3T3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-117-011 in 1 CARTON05/18/2012
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11673-117-022 in 1 CARTON05/18/201207/10/2018
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11673-117-033 in 1 CARTON05/18/2012
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20231905/18/2012
    Labeler - Target Corporation (006961700)
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