Label: LANSOPRAZOLE capsule, delayed release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 10, 2012

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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

    • 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

    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.

  • 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
  • Inactive ingredients

    colloidal silicon dioxide, D & C Red No. 33, D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-346-6854

    Poison Control Center:

    Call 1-800-222-1222

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Wockhardt Limited

    Mumbai, India.

    Distributed by:

    Wockhardt USA LLC.

    20 Waterview Blvd.

    Parsippany, NJ 07054

    USA.

    Iss.130212

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Bottle Label
    Bottle Carton
    Bottle Carton
    Bottle Carton
    Bottle Label
  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-140
    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. 33 (UNII: 9DBA0SBB0L)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    Product Characteristics
    ColorPINK (Opaque dark pink cap) , GREEN (Opaque dark green body) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code W;140
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55648-140-004500 in 1 POUCH
    2NDC:55648-140-011 in 1 CARTON
    214 in 1 BOTTLE
    3NDC:55648-140-082 in 1 CARTON
    314 in 1 BOTTLE
    4NDC:55648-140-093 in 1 CARTON
    414 in 1 BOTTLE
    5NDC:55648-140-071 in 1 CARTON
    514 in 1 BLISTER PACK
    6NDC:55648-140-102 in 1 CARTON
    614 in 1 BLISTER PACK
    7NDC:55648-140-113 in 1 CARTON
    714 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20272705/18/2012
    Labeler - Wockhardt Limited (650069115)
    Registrant - Wockhardt Limited (650069115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wockhardt Limited916489953Manufacture
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