Label: OMEPRAZOLE- omeprazole tablet, delayed release

  • NDC Code(s): 69230-318-05, 69230-318-10, 69230-318-14, 69230-318-31, view more
    69230-318-32, 69230-318-33, 69230-318-34, 69230-318-35, 69230-318-36, 69230-318-37
  • Packager: Camber Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 17, 2020

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

  • Active ingredient (in each tablet)

    Omeprazole delayed-release tablet, 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.

  • 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 tablet with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 14 days unless directed by your doctor
    • swallow whole. Do not chew or crush tablets.
    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° to 25° C (68° to 77° F) and protect from moisture


  • Inactive ingredients


    colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

  • Questions?

    1-888-588-1418

  • PRINCIPAL DISPLAY PANEL

     

    NDC 69230-318-35

    Compare to Prilosec OTC ®*

    Omeprazole
    Delayed-Release Tablets
    20 mg

    Acid Reducer

    Treats FREQUENT Heartburn!
    Occuring 2 Or More Days A Week

    24 HR

    One 14-day course of treatment

    14 TABLETS omecarton

  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE  
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 68401960MK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    SUCROSE (UNII: C151H8M554)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code H;O9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-318-351 in 1 CARTON03/25/2020
    1NDC:69230-318-3114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-318-362 in 1 CARTON03/25/2020
    2NDC:69230-318-3114 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-318-373 in 1 CARTON03/25/2020
    3NDC:69230-318-3114 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69230-318-321 in 1 CARTON03/25/2020
    4NDC:69230-318-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:69230-318-332 in 1 CARTON03/25/2020
    5NDC:69230-318-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:69230-318-343 in 1 CARTON03/25/2020
    6NDC:69230-318-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:69230-318-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
    8NDC:69230-318-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21173203/25/2020
    Labeler - Camber Consumer Care (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited Unit III676162024analysis(69230-318) , manufacture(69230-318)