Label: LANSOPRAZOLE- lansoprazole capsule, delayed release 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • Active ingredient (in each capsule)

    Lansoprazole 15 mg

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  • Purpose

    Acid reducer

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  • 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
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  • 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
    • 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.

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  • 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. Patients should use the lowest dose and shortest duration of this therapy.
    • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
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  • 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
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  • 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

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN PREVACID® 24 HR*

    Lansoprazole

    Delayed-Release Capsules, 15 mg

    Acid Reducer

    • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
    • Clinically Proven To Treat Frequent Heartburn

    Sodium Free

    CAPSULES

    KEEP CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

    TAMPER-EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED FOR YOUR PROTECTION” OR DARK BLUE TO BLACK GELATIN BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

    KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    KANSAS CITY, KS 66106

    www.awgbrands.com

    Product of India

    *Prevacid® 24 HR is a registered trademark of Takeda Pharmaceuticals North America, Inc., and is used under license.
    © 2012 Novartis Consumer Health, Inc.

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  • Product Label

    Lansoprazole 15 mg

    BEST CHOICE Lansoprazole Acid Reducer Capsule

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  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63941-019(NDC:55648-140)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    HYPROMELLOSES  
    MAGNESIUM CARBONATE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    SILICON DIOXIDE  
    STARCH, CORN  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
    Product Characteristics
    Color PINK, GREEN Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code W140
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63941-019-14 1 in 1 BOX
    1 14 in 1 BOTTLE
    2 NDC:63941-019-42 3 in 1 BOX
    2 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202727 04/30/2012
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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