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

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension Maximum Strength by

Drug Labeling and Warnings

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Drug Facts

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

• age:

  dose

• Adults and children 12 years and older:

  30mL, not more than 120 mL in 24 hrs

• Children under 6 years of age:

  Do not use unless directed by a doctor

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

• age:

  dose

• Adults and children 12 years and older:

  30mL, not more than 60 mL in 24 hrs

• Children under 6 years of age:

  Do not use unless directed by a doctor

Other information

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

• each 30 mL containsmagnesium 510 mg and sodium 18 mg
• protect from freezing
• store at 20° to 25°C (68° to 77°F).
• do not use if lid seal is open or damaged
• retain this insert for full product information

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

• each 30 mL containsmagnesium 990 mg, sodium 30 mg
• store at 20° to 25°C (68° to 77°F). 
• protect from freezing
• do not use if lid seal is open or damaged
• retain this insert for full product information

INACTIVE INGREDIENT

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

QUESTIONS

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

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

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	1200 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 30 mL
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE, UNSPECIFIED - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	120 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7325-73	10 in 1 CASE	08/01/2023	04/30/2026
1		10 in 1 TRAY
1	NDC: 0904-7325-62	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	07/05/2023	04/30/2026

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7326
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	2400 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	2400 mg  in 30 mL
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE, UNSPECIFIED - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	240 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7326-73	10 in 1 CASE	08/01/2023	11/30/2024
1		10 in 1 TRAY
1	NDC: 0904-7326-62	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	08/01/2023	11/30/2024

Labeler - Major Pharmaceuticals (191427277)