ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, and simethicone suspension 
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION- aluminum hydroxide, magnesium hydroxide, and simethicone suspension 
MAJOR® PHARMACEUTICALS

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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Magnesium Hydroxide, Aluminum Hydroxide and Simethicone Suspension 1,200-1,200-120 mg/30 mL,
Magnesium Hydroxide, Aluminum Hydroxide and Simethicone Suspemsion Maximum Strength 2,400-2,400-240 mg/30 mL

Drug Facts

1,200-1,200-120 mg/30 mL

Active ingredients (in each 30 mL)                                               Purpose 

Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 1,200 mg......................................................Antacid
Simethicone 120 mg......................................................................Antigas

2,400-2,400-240 mg/30 mL

Active ingredient (in each 30 mL)                                               Purpose
Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 2,400 mg......................................................Antacid
Simethicone 240 mg......................................................................Antigas

Usesrelieves • heartburn • sour stomach • acid indigestion • the symptoms 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 aretaking another medication. This product may interact with certain medications.

Stop use and ask a doctor ifsymptoms last more than 2 weeks

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.

Directions • shake well before use

1,200-1,200-120 mg/30 mL

 agedose
Adults and children 12 years and older30mL, not more than 120 mL in 24 hrs 
Children under 6 years of ageDo not use unless directed by a doctor

2,400-2,400-240 mg/30 mL

 agedose
Adults and children 12 years and older30mL, not more than 60 mL in 24 hrs
Children under 6 years of ageDo not use unless directed by a doctor

Other information

1,200-1,200-120 mg/30 mL

2,400-2,400-240 mg/30 mL

Inactive ingredientsbenzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?(855) 879-4368

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

(800) 616-2471

Rev. 06/23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7325-62

Each 30 mL Contains:

Magnesium hydroxide 1,200 mg

Aluminum hydroxide 1,200 mg 

Simethicone 120 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

aapdp

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7326-62

Each 30 mL Contains:

Magnesium hydroxide 2,400 mg

Aluminum hydroxide 2,400 mg 

Simethicone 240 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

aampdp

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7326
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7326-7310 in 1 CASE08/01/2023
110 in 1 TRAY
1NDC:0904-7326-6230 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/01/2023
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1200 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 30 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE120 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7325-7310 in 1 CASE08/01/2023
110 in 1 TRAY
1NDC:0904-7325-6230 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/05/2023
Labeler - MAJOR® PHARMACEUTICALS (191427277)

Revised: 8/2023
Document Id: 027676c5-bd0b-ca4a-e063-6394a90ae75c
Set id: 0cab04e3-8b95-48bd-8bd0-2f7fef4addc0
Version: 1
Effective Time: 20230801
 
MAJOR® PHARMACEUTICALS