Label: GELUSIL- aluminum hydroxide, magnesium hydroxide, dimethicone and silicon dioxide tablet, chewable

  • NDC Code(s): 65197-300-10
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • Active Ingredients (in each tablet)  

    Aluminum hydroxide dried gel 200 mg
    Magnesium hydroxide 200 mg
    Simethicone 25 mg

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  • Purpose

    Active ingredients (in each tablet)                  Purpose
    Aluminum hydroxide dried gel 200 mg........................Antacid
    Magnesium hydroxide 200 mg....................................Antacid
    Simethicone 25 mg......................................................Antigas

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  • Uses

    Relieves:

    • heartburn
    • sour stomach
    • acid indigestion
    • bloating, pressure and discomfort commonly referred to as gas
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  • Warnings

    Ask a doctor before use if you have

    • Kidney disease
    • A magnesium restricted diet

    Ask a doctor or pharmacist before use if you are

    now taking a prescription drug.  Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if

    symproms last more than 2 weeks

    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

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  • Directions

    • Chew 2 to 4 tablets.  Repeat hourly if symptoms return, or as directed by a physician
    • Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician
    • Children under 12: ask a doctor
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  • Other information

    • Each tablet contains: magnesium 95 mg
    • Store at 59º to 77º (15º to 25ºC)
    • Tamper Evident. Do not use if blister or printed Gelusil foil seal is broken
    • See send panel for lot number and expiration date
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  • Inactive ingredients

    Flavors, magnesium stearate, mannitol, saccharin sodium, sorbitol, and sugar

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  • Questions?

    Call 1-866-337-4500

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  • SPL UNCLASSIFIED SECTION

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243 USA
    © WellSpring 2013   Made in Canada

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  • Package Label

    Carton 

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  • INGREDIENTS AND APPEARANCE
    GELUSIL 
    aluminum hydroxide dried gel and magnesium hydroxide and simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65197-300
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 200 mg
    DIMETHICONE (DIMETHICONE) DIMETHICONE 24 mg
    SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    MANNITOL  
    RAW SUGAR  
    MAGNESIUM STEARATE  
    SORBITOL  
    SACCHARIN SODIUM  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 16mm
    Flavor PEPPERMINT Imprint Code PD;GELUSIL;034
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65197-300-10 10 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part331 09/24/2008
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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