Label: GELUSIL- alumina, magnesia, simethicone 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

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 September 5, 2016

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

    symptoms 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

    If pregnant or breastfeeding

     ask a health professional before use.

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  • Directions

    • For adults and children 12 years of age and older: 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

    Dextrose, flavors, magnesium stearate, maltodextrin, silica, sucralose

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  • Questions?

    Call 1-844-241-5454

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  • SPL UNCLASSIFIED SECTION

    © WellSpring 2016
    Sarasota, FL 34243 USA
    Made in USA

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  • Principal display panel - Carton

     Raritan Carton

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  • INGREDIENTS AND APPEARANCE
    GELUSIL 
    alumina, magnesia, simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-300
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 24 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON (UNII: Z4152N8IUI)  
    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 09/24/2008
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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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