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NDC 66689-0060-99 Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL Details

Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL

Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength 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: 66689-0060-99
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: 66689-0060-99
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	66689-0060
Product ID	66689-060_0ac07cda-92d2-49cb-847e-bd88c4990bcf
Associated GPIs	48991003101810
GCN Sequence Number	002701
GCN Sequence Number Description	mag hydrox/aluminum hyd/simeth ORAL SUSP 200-200-20 ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	63910
HICL Sequence Number	001168
HICL Sequence Number Description	MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alumina, Magnesia, and Simethicone Oral Suspension Regular Strength
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	1200; 120; 1200
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 66689-0060-99 (66689006099)

Pricing Information	N/A
NDC Package Code	66689-060-99
Billing NDC	66689006099
Package	100 CUP, UNIT-DOSE in 1 CASE (66689-060-99) / 30 mL in 1 CUP, UNIT-DOSE (66689-060-01)
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4918a70-d9b2-408b-966f-d54631e8b1b7 Details

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

Labeler - VistaPharm, Inc. (116743084)

Revised: 7/2022

Document Id: 0ac07cda-92d2-49cb-847e-bd88c4990bcf

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

Version: 7

Effective Time: 20220707