Your browser does not support JavaScript! GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]
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RxNorm Names

GELUSIL (aluminum hydroxide dried gel and magnesium hydroxide and simethicone) tablet, chewable
[WellSpring Pharmaceutical Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 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

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

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

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

Inactive ingredients

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

Questions?

Call 1-866-337-4500

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

Package Label

Carton 

GELUSIL 
aluminum hydroxide dried gel and magnesium hydroxide and simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65197-300
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE200 mg
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE200 mg
DIMETHICONE (DIMETHICONE) DIMETHICONE24 mg
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE1 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL 
RAW SUGAR 
MAGNESIUM STEARATE 
SORBITOL 
SACCHARIN SODIUM 
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 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33109/24/2008
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 11/2013
 
WellSpring Pharmaceutical Corporation

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