Label: LANSOPRAZOLE 24 HR- lansoprazole capsule, delayed release

  • NDC Code(s): 62175-515-12, 62175-515-24, 62175-515-52
  • Packager: Lannett Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 29, 2020

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

  • Active ingredient

    Lansoprazole 15mg

  • Purpose

    Acid reducer

  • Uses

    ● 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.

  • 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 Course of Treatment (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

    ● close cap tightly after use

  • Inactive Ingredients

    ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide yellow, isopropyl alcohol, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, sodium starch glycolate, sugar sphere, talc, titanium dioxide

  • Questions or Comments

    1-844-834-0530

    Distributed by:

    Lannett Company, Inc.

    Philadelphia, PA 19136

    CIA79102B

    Rev. 06/20

  • Package/Label Principal Display Panel

    carton
  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE  24 HR
    lansoprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62175-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXIDE ION (UNII: 9159UV381P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    MANNITOL (UNII: 3OWL53L36A)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (opaque green cap) , WHITE (opague white body) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code KU;515
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62175-515-241 in 1 CARTON09/29/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62175-515-122 in 1 PACKAGE, COMBINATION09/29/2017
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:62175-515-523 in 1 PACKAGE, COMBINATION09/29/2017
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20715709/29/2017
    Labeler - Lannett Company, Inc. (006422406)