Label: EQUALINE LANSOPRAZOLE- lansoprazole capsule, delayed release

  • NDC Code(s): 41163-150-01, 41163-150-03
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 21, 2023

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

  • 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 care 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 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
    close cap tightly after use
  • Inactive ingredients

    D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, 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 or comments?

    1-855-423-2630

  • Package/Label Principal Display Panel

    EQUALINE®

    compare to Prevacid® 24 HR active ingredient

    24 HOUR

    lansoprazole

    delayed-release capsules 15mg (acid reducer)

    • may take 1 to 4 days for full effect

    • sodium free

    treats frequent heartburn

    actual size

    14 capsules

    one14-day course of treatment

    lansoprazole image-1
    lansoprazole image-2
  • INGREDIENTS AND APPEARANCE
    EQUALINE LANSOPRAZOLE 
    lansoprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-150
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    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
    ShapeCAPSULESize15mm
    FlavorImprint Code 24HR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-150-011 in 1 CARTON09/02/2021
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41163-150-033 in 1 CARTON09/28/2021
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20231909/02/2021
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)