Label: ESTOMAROL- aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate powder

  • NDC Code(s): 57465-100-00
  • Packager: Laboratorios Imperiales, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 24, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    In each pack

    Aluminum Hydroxide 0.18g

    Bismuth Subcarbonate 0.21g

    Calcium Carbonate 0.25g

    Magnesium Carbonate 0.59g

    Sodium Bicarbonate 2.27g


  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    • For the relief of heartburn, sour stomach, and acid indigestion
  • DOSAGE & ADMINISTRATION

    Directions

    Add packet (3.5g) to a cup of water after each meal taken, maximum of 6 doses in 24 hours or as directed by a physician.

  • SPL UNCLASSIFIED SECTION

    Other information

    In each pack:

    Calcium 95mg, Magnesium 145mg, and Sodium 605mg.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Colloidal silicon dioxide, glycerine anyhydrous, peppermint oil

  • WARNINGS

    Warnings

    • Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.
  • WHEN USING

    When using this product

    • Do not take more than 6 doses in 24-hour period, or use more than 2 weeks, except under the advice and supervision of a physician.
    • Do not use this product except under the advice and supervision of a physician if you have kidney disease or are on a sodium restricted diet.
    • Do not take this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.
    • Do not use if you are pregnant or lactating.
    • Use caution in patients who are taking anticoagulants or who are diabetic.
    • Do not administer to adolescents who have or have recently had chicken pox
    • This medication can cause constipation and in large doses can cause diarrhea, dark urine and dark bowel movements.
    • Do not give to children under 6
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Estomarol

    Antacid Powder

    LIMSA

    15-0.12 oz packets (3.5g) - Net Wt. 1.9 oz (52.5 g)


    EstomarolPacket


    EstomarolA


    EstomarolB


    EstomarolC

    EstomarolD

  • INGREDIENTS AND APPEARANCE
    ESTOMAROL 
    aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57465-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE0.18 g  in 3.5 g
    BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBCARBONATE0.21 g  in 3.5 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE0.25 g  in 3.5 g
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE0.59 g  in 3.5 g
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE2.27 g  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57465-100-0015 in 1 BOX05/11/2011
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/11/2011
    Labeler - Laboratorios Imperiales, S.A. de C.V. (812643138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Imperiales, S.A. de C.V.812643138manufacture(57465-100)