ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE- aluminum hydroxide, magnesium hydroxide, and simethicone suspension 
Rising Pharma Holdings, Inc.

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

Drug Facts

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

Active ingredient per 30mL (1 Unit Dose)                                                                                                                                        
Aluminum hydroxide 1,200mg (equivalent to dried gel USP)
Magnesium hydroxide 1,200mg
Simethicone 120mg

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

Active ingredient per 30mL (1 Unit Dose)
Aluminum hydroxide 2,400mg (equivalent to dried gel USP)
Magnesium hydroxide 2,400mg
Simethicone 240mg

​Purpose

Antacid

Antigas

Uses

relieves

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

Stop use and ask a doctor if symptoms last more than 2 weeks

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions • shake well before use

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

•   Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 agedose
Adults and children over 12 years of ageTake 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period
Children under 12 years of ageAsk a doctor 

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

•   Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 agedose
Adults and children over 12 years of ageTake 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period
Children under 12 years of ageAsk a doctor

Other information

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

   each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broke

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

•   each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broken

1,200-1,200-120 mg/30 mL / 2,400-2,400-240 mg/30 mL

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

NDC Information -


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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms:

NDC 57237-316-03 unit dose cup 30 mL
NDC 57237-316-31 (100 x 30 mL) unit-dose cups


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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms:

NDC 57237-324-03 unit dose cup 30 mL
NDC 57237-324-31 (100 x 30 mL) unit-dose cups

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Case Label NDC 57237-316-31

Mag-Al-Case-Lab-01

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

Lid Label NDC 57237-316-03

Mag-Al-Lid-Lab-01

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

Case Label NDC 57237-324-31

Mag-Al-Case-Lab-02

2,400-2,400-240 mg/30 mL
Lid Label NDC 57237-324-03

Mag-Al-Lid-Lab-02

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-316
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
ColorwhiteScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-316-31100 in 1 BOX, UNIT-DOSE08/15/2023
1NDC:57237-316-0330 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 DrugM001.1508/15/2023
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
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
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-324-31100 in 1 BOX, UNIT-DOSE07/05/2023
1NDC:57237-324-0330 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 DrugM001.1507/05/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 7/2025
Document Id: ea8b3419-ff01-4c21-9308-74ff70433ca0
Set id: 982129d4-3cbf-4793-a861-d6c8f34bedc3
Version: 3
Effective Time: 20250701
 
Rising Pharma Holdings, Inc.