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

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.

Directions

Other information

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

VP2184
05/20

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

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

Distributed by: VistaPharm

Largo, FL 33771, USA  

VP2187

Rev.06/20

NDC 66689-060-01

Lidding Label
ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH 
alumina, magnesia, and simethicone oral suspension regular strength suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66689-060
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) 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)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorWHITE (white suspension) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66689-060-99100 in 1 CASE09/15/2020
1NDC:66689-060-0130 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 FINALpart33109/15/2020
Labeler - VistaPharm, Inc. (116743084)

Revised: 9/2020
Document Id: dc06336f-065d-4e5e-ad67-88e68d833c05
Set id: b4918a70-d9b2-408b-966f-d54631e8b1b7
Version: 2
Effective Time: 20200914
 
VistaPharm, Inc.