Label: OMEPRAZOLE capsule, delayed release

  • NDC Code(s): 51660-061-14, 51660-061-27, 51660-061-44
  • Packager: Ohm Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    *Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)

  • 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 omeprazole

    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

    • 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

    • for 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; 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
      • do not use for more than 14 days unless directed by your doctor
      • swallow whole. Do not chew or crush capsules.
      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. 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). [See USP controlled room temperature]. Protect from moisture
  • Inactive ingredients

    FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

  • Questions?

    Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901

  • PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

    †Compare To
    the active ingredient of
    Prilosec OTC®

    NDC 51660-061-27

    2x14 COUNT BOTTLE INSIDE

    Treats FREQUENT Heartburn!
    24
    HR

    Omeprazole
    Delayed-release Capsules
    20 mg* / Acid Reducer

    ohm®

    28 CAPSULES
    Two 14-day courses of treatment
    May take 1 to 4 days for full effect

    PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code RG;49
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-061-443 in 1 CARTON07/21/2018
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51660-061-272 in 1 CARTON07/21/2018
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:51660-061-141 in 1 CARTON07/21/2018
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21059307/21/2018
    Labeler - Ohm Laboratories Inc. (184769029)
    Registrant - Ohm Laboratories Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(51660-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Srini Pharmaceuticals Private Limited725914795API MANUFACTURE(51660-061)
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