Search by Drug Name or NDC

NDC 66689-0061-99 Alumina, Magnesia, and Simethicone 2400; 240; 2400 mg/30mL; mg/30mL; mg/30mL Details

Alumina, Magnesia, and Simethicone 2400; 240; 2400 mg/30mL; mg/30mL; mg/30mL

Alumina, Magnesia, and Simethicone is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by VistaPharm, Inc.. The primary component is ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE.

MedlinePlus Drug Summary

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 66689-0061-99
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aluminum Hydroxide and Magnesium Hydroxide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 66689-0061-99
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	66689-0061
Product ID	66689-061_47da223d-7ce8-468b-999d-8ca302fb4ce6
Associated GPIs	48991003101835
GCN Sequence Number	002706
GCN Sequence Number Description	mag hydrox/aluminum hyd/simeth ORAL SUSP 400-400-40 ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	63915
HICL Sequence Number	001168
HICL Sequence Number Description	MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Alumina, Magnesia, and Simethicone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alumina, Magnesia, and Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	2400; 240; 2400
Active Ingredient Units	mg/30mL; mg/30mL; mg/30mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	VistaPharm, Inc.
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2023-12-31

Package

Package Images

NDC 66689-0061-99 (66689006199)

Pricing Information	N/A
NDC Package Code	66689-061-99
Billing NDC	66689006199
Package	100 CUP, UNIT-DOSE in 1 CASE (66689-061-99) / 30 mL in 1 CUP, UNIT-DOSE (66689-061-01)
Marketing Start Date	2020-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6458dbb6-e433-4f28-bd5f-92986a7a8978 Details

Drug Facts

Active ingredients

(in each 30 mL dose)

Aluminum hydroxide 2400 mg

(equivalent to dried gel, USP)

Magnesium hydroxide 2400 mg

Simethicone 240 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 60 mL (2 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 2 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 990 mg, sodium 30 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, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline 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 66689-061-01: 30 mL unit-dose cup

NDC 66689-061-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-061-01), packaged in 10 trays of 10 unit-dose cups each.

Distributed by:

VistaPharm Inc.

Largo, FL 33771, USA

VP2526

08/20

Principal Display Panel

MAXIMUM STRENGTH

Alumina, Magnesia, and

Simethicone Oral Suspension

each 30 mL contains:

Aluminum Hydroxide Gel…………2400 mg

Magnesium hydroxide…………….2400 mg

Simethicone………………………..240 mg

Alcohol 0.5%

Delivers 30 mL

For Institutional Use Only

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

Distributed by:

VistaPharm

Largo, FL 33771, USA

VP2183R1

Rev.05/22

NDC 66689-061-01

INGREDIENTS AND APPEARANCE

ALUMINA, MAGNESIA, AND SIMETHICONE

alumina, magnesia, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66689-061(NDC:57896-619)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	2400 mg in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	2400 mg in 30 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	240 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66689-061-99	100 in 1 CASE	09/30/2020
1	NDC:66689-061-01	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	09/30/2020

Labeler - VistaPharm, Inc. (116743084)

Revised: 7/2022

Document Id: 47da223d-7ce8-468b-999d-8ca302fb4ce6

Set id: 6458dbb6-e433-4f28-bd5f-92986a7a8978

Version: 5

Effective Time: 20220707