GELUSIL MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide and dimethicone suspension 
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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Gelusil Liquid Maximum Strength

Active ingredients

Active ingredients (in each 5mL teaspoonful)  
Aluminum hydroxide (equivalent to Dried Gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg

Purpose

Active ingredients (in each 5mL teaspoonful) 
Aluminum hydroxide (equivalent to Dried Gel, USP) 400 mg..........Antacid 
Magnesium hydroxide 400 mg.......................................................Antacid
Simethicone 40 mg.........................................................................Antigas 

Uses

relieves

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

Warning

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

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

Stop use and ask a doctor if

symptoms last for more than 2 weeks

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • shake well before use
  • do not exceed 12 teaspoonfuls (60 mL) in a 24 hour period or use the maximum dosage for more than 2 weeks
  • adults & children 12 years of age and older: take 2 to 4 teaspoonfuls (10-20 mL) between meals, at bedtime or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

  • each 5 mL teaspoonful contains:  magnesium 165 mg, sodium 1 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions?

Call 1-866-337-4500

TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Distibuted by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 USA
© WellSpring 2013
Made in USA

981-06242-0 REV GC0413

Package Label Principal Display Panel

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GELUSIL MAXIMUM STRENGTH 
aluminum hydroxide and magnesium hydroxide and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-310
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (COOL MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65197-310-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33108/01/201302/28/2016
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 6/2013
Document Id: 04943fb6-703f-4af5-9851-aeccfa41a734
Set id: 626ebd0b-5137-4d88-9fce-01fe498757fd
Version: 4
Effective Time: 20130604
 
WellSpring Pharmaceutical Corporation