Label: GELUSIL- alumina, magnesia, simethicone tablet, chewable

  • NDC Code(s): 65197-300-10, 65197-300-11
  • 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 November 21, 2022

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

View All Sections
  • Active Ingredients (in each tablet)  

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

  • Purpose

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

  • Uses

    Relieves:

    •
    Heartburn
    •
    Sour stomach
    •
    Acid indigestion
    •
    Bloating, pressure and discomfort commonly referred to as gas
  • 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.

  • Directions

    •
    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
    •
    Children under 12 of age: ask a doctor
    •
    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
  • Other information

    •
    Each tablet contains: magnesium 95 mg
    •
    Store below 30°C (86°F)
    •
    Tamper Evident. Do not use if blister or printed Gelusil foil seal is broken
    •
    See end panel for lot number and expiration date
  • Inactive ingredients

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

  • Questions?

    Call 1-844-241-5454

    © WellSpring 2018

    Sarasota, FL 34243 USA

    Made in USA

  • Principal display panel - Carton

     Gelusil Antacid Antigas 10 Blisters

    Gelusil Antacid 100 Chewable Tablets

    Gelusil Antacid Antigas Cool mint 100 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    GELUSIL 
    alumina, magnesia, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE24 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON (UNII: Z4152N8IUI)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code PD;GELUSIL;034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-300-1010 in 1 CARTON09/24/2008
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65197-300-11100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/24/2008
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!