Label: LANSOPRAZOLE tablet, orally disintegrating, delayed release

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

Drug Label Information

Updated February 8, 2025

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

  • Active ingredient (in each tablet)

    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.
    lansoprazole may cause severe skin reactions. Symptoms may include:
    skin reddening
    blisters
    rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use if you have:

    trouble or pain swallowing food, vomiting with blood, or bloody or black stools
    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

    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.
    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 and warnings before use
    keep the carton. It contains important information.
    store at 20-25°C (68-77°F)
    keep product out of high heat and humidity
    protect product from moisture
    take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.
  • 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

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredient in Prevacid® 24 HR *see side panel

    Kroger®

    OUR PHARMACIST RECOMMENDED

    Lansoprazole

    Delayed Release Orally Disintegrating Tablets 15 mg

    MELTech®

    Melts In Your Mouth

    ACID REDUCER

    Treats FREQUENT Heartburn

    24 HR

    Dissolve Tabs

    MELTS IN YOUR MOUTH

    Dissolves without water

    actual size

    42 TABLETS

    May take 1 to 4 days for full effect

    Strawberry Flavor

    Three 14-Day Courses of Treatment

    May Take 1 to 4 Days for Full Effect

    kroger-lansoprazole-strawberry-carton-image-1.jpg
    kroger-lansoprazole-strawberry-carton-image-2.jpg
  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole tablet, orally disintegrating, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-192
    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, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTITOL (UNII: D65DG142WK)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    MICROCRYSTALLINE CELLULOSE (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
    FlavorImprint Code 15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-192-553 in 1 CARTON04/05/2019
    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
    NDANDA20802504/05/2019
    Labeler - Kroger Company (006999528)