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

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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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 finalpart33108/15/2023
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 finalpart33107/05/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 8/2023
Document Id: ab66959e-fe45-468f-aebd-87087d1f6738
Set id: 982129d4-3cbf-4793-a861-d6c8f34bedc3
Version: 1
Effective Time: 20230824
 
Rising Pharma Holdings, Inc.