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Lansoprazole (Dr. Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
CAPSULE, DELAYED RELEASE 3 BOTTLE in 1 PACKAGE, COMBINATION (55111-739-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 2 BOTTLE in 1 PACKAGE, COMBINATION (55111-739-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE Label Information
CAPSULE, DELAYED RELEASE 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-739-52) Label Information

Complete Lansoprazole Information

  • Active ingredient(s)

    Lansoprazole  USP, 15 mg


  • Purpose

    Acid reducer


  • Use(s)

    • 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 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)


  • 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 days
    • 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

    FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide


  • Questions or comments?

    call 1-888-375-3784

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachupally - 500 090 INDIA


  • Principal Display Panel

    Container : 14's count

    container


  • Principal Display Panel

    Container carton : 14's count

    containercarton


  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-739
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lansoprazole (UNII: 0K5C5T2QPG) (Lansoprazole - UNII:0K5C5T2QPG) Lansoprazole 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color PINK (opaque pink colored cap) , GREEN (opaque green colored body) Score no score
    Shape CAPSULE Size 3mm
    Flavor Imprint Code RDY;398
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-739-52 14 in 1 BOTTLE
    2 NDC:55111-739-27 2 in 1 PACKAGE, COMBINATION
    2 14 in 1 BOTTLE
    3 NDC:55111-739-33 3 in 1 PACKAGE, COMBINATION
    3 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202194 05/18/2012
    Labeler - Dr. Reddy's Laboratories Limited (650562841)
    Establishment
    Name Address ID/FEI Business Operations
    Dr.Reddy's Laboratories Limited (FTO III) 918608162 manufacture(55111-739) , analysis(55111-739)