Alumina, Magnesia, and Simethicone Oral SuspensionRegular Strength

Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength by

Drug Labeling and Warnings

Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength by is a Otc medication manufactured, distributed, or labeled by VistaPharm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH- alumina, magnesia, and simethicone oral suspension regular strength suspension 
VistaPharm, LLC

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Alumina, Magnesia, and Simethicone Oral Suspension
Regular Strength

Drug Facts

Active ingredients                                                             

(in each 30 mL dose)

Aluminum hydroxide 1200 mg

(equivalent to dried gel, USP)

Magnesium hydroxide 1200 mg

Simethicone 120 mg

Purposes

Aluminum hydroxide............................................Antacid 

(equivalent to dried gel, USP)

Magnesium hydroxide..........................................Antacid

Simethicone.........................................................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. Antacid may interact with certain prescription drugs.

When using this product

• do not take more than 120 mL (4 doses) in a 24-hour period 
• do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
  

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

Keep out of reach of children.

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

Directions

• shake well before use
• adults and children 12 years and older: 30 mL (1 dose) up to 4 times a day or as directed by a doctor 
• children under 12 years of age: ask a doctor
  

Other information

• each 30 mL contains: magnesium 510 mg, sodium 18 mg
• store at 20-25°C (68-77°F)
• protect from freezing
• keep tightly closed
• tamper-evident: do not use if foil on cup is missing or torn
  

Inactive ingredients

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethyl cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

Call 1-888-655-1505

How Supplied

Alumina, Magnesia, and Simethicone Oral Suspension is a white suspension supplied as follows:

NDC: 66689-060-01: 30 mL unit-dose cup
NDC: 66689-060-99: Case contains 100 unit-dose cups of 30 mL (NDC: 66689-060-01), packaged in 10 trays of 10 unit-dose cups each.

Distributed by:
VistaPharm Inc.
Largo, FL 33771, USA

VP2184R1
01/2022

Principal Display Panel

REGULAR STRENGTH

Alumina, Magnesia, and

Simethicone Oral Suspension

each 30 mL contains:

Aluminum Hydroxide Gel…………1200 mg

Magnesium hydroxide…………….1200 mg

Simethicone………………………..120 mg

Alcohol 0.15%

Delivers 30 mL

For Institutional Use Only

Store at 20°-25°C (68°-77°F). Shake Well

Distributed by: VistaPharm

Largo, FL 33771, USA  

VP2187R1

Rev. 05/22

NDC: 66689-060-01

 

ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH 
alumina, magnesia, and simethicone oral suspension regular strength suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66689-060(NDC: 57896-629)
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)	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)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	white (white suspension)	Score
Shape		Size
Flavor	LEMON (citrus mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66689-060-99	100 in 1 CASE	09/15/2020	08/31/2023
1	NDC: 66689-060-01	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	09/15/2020	08/31/2023

Labeler - VistaPharm, LLC (116743084)

Revised: 12/2023

Document Id: 38e26f1f-7517-4b6f-8e6a-0338a9fef7cd

34390-5

Set id: b4918a70-d9b2-408b-966f-d54631e8b1b7

Version: 8

Effective Time: 20231211