GELUSIL- aluminum hydroxide, dimethicone 410, magnesium hydroxide and silicon dioxide tablet, chewable 
WellSpring Pharmaceutical Corporation

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.

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Active Ingredients

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

Uses

Relieves:

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

Warnings

Do not use if you are presently taking a prescription antibiotic drug containing any form of tetracycline

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

Other information

  • each tablet contains: magnesium 95 mg
  • store at 59º to 77º (15º to 25ºC)
  • do not use if blister or printed Gelusil foil seal is broken
  • see side panel for lot number and expiration date

Inactive ingredients

flavors, magnesium stearate, mannitol, sorbitol, and sugar

Questions?

call 1-866-337-4500

Distributed by:
WellSpring Pharmaceutical Corporation
SARASOTA, FL 34243 USA
©WellSpring 2010         Made in Canada

Package Label

Package Label

Package Label for Blister Pack

Blister Pack

Purpose

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

GELUSIL 
aluminum hydroxide dried gel and magnesium hydroxide and simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-300
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE200 mg
DIMETHICONE 410 (DIMETHICONE 410) DIMETHICONE 41024 mg
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE200 mg
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE1 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL 
RAW SUGAR 
MAGNESIUM STEARATE 
SORBITOL 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code PD;GELUSIL;034
Contains    
Packaging
#Item CodePackage Description
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)
Establishment
NameAddressID/FEIBusiness Operations
Trillium Health Care Manufacturing Inc.255426306MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
WellSpring Pharmaceutical Corporation110999054MANUFACTURE

Revised: 01/2011
Document Id: 136e1dde-f967-49cb-890a-63792904c8c6
Set id: 92fbeec1-1562-40f3-9734-41f133d494f9
Version: 7
Effective Time: 20110103
 
WellSpring Pharmaceutical Corporation