Label: ACID REDUCER- omeprazole tablet, delayed release

  • NDC Code(s): 58602-826-05, 58602-826-61, 58602-826-62
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2019

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

  • Tips for Managing Heartburn

    • Do not lie flat or bend over after eating
    • Do not wear tight-fitting clothing around the stomach
    • Do not eat before bedtime
    • Raise the head of your bed
    • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
    • Eat slowly and avoid big meals
    • If overweight, lose weight
    • Quit smoking
  • Drug Facts

  • 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 (1-800-222-1222)  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 1 tablet a day
    • do not use for 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 20º to 25ºC (68º to 77º F) and protect from moisture
  • Inactive ingredients

    crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

  • Questions?

    Call 1-855-274-4122

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India

    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

    NDC 58602-826-05         PrimaryHealth
    See current Drug Facts
    Acid Reducer

    Omeprazole
    Delayed-Release
    Tablets 20 mg
    Treats Frequent Heartburn!
    24 HR
    14 TABLETS
    One 14-day course of treatment
    May take 1 to 4 days for full effect



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

    NDC 58602-826-05
    PrimaryHealth
    COMPARE TO Prilosec OTC®
    Active ingredient*
    See current Drug Facts
    ACID REDUCER

    Omeprazole
    Delayed-Release
    Tablets 20 mg
    Treats Frequent Heartburn!
    24 HR
    14 TABLETS
    One 14-day Course of Treatment
    May take 1 to 4 days for full effect



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-826
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeRECTANGLE (Oblong) Size14mm
    FlavorImprint Code Z;69
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-826-051 in 1 CARTON06/06/2018
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-826-612 in 1 CARTON06/06/2018
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-826-623 in 1 CARTON06/06/2018
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20687706/06/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-826) , MANUFACTURE(58602-826)