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

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone by

Drug Labeling and Warnings

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Drug Facts

ACTIVE INGREDIENT

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

• age: dose
• Adults and children over 12 years of age: Take 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 age: Ask 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

• age: dose
• Adults and children over 12 years of age: Take 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 age: Ask 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

INACTIVE INGREDIENT

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

QUESTIONS

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

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

Lid Label NDC: 57237-316-03

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

Case Label NDC: 57237-324-31

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-316
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 (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	120 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-316-31	100 in 1 BOX, UNIT-DOSE	08/15/2023
1	NDC: 57237-316-03	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 final	part331	08/15/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-324
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 (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	240 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-324-31	100 in 1 BOX, UNIT-DOSE	07/05/2023
1	NDC: 57237-324-03	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 final	part331	07/05/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)