Alumina, Magnesia, and Simethicone Oral Suspension Maximum Strength

Manufacturer
VistaPharm, Inc.
Effective date
2022-07-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:57:25

Label at a glance#

ProductAlumina, Magnesia, and Simethicone
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure10 sections

Indications and uses

relieves: heartburn sour stomach acid indigestion the symptoms referred to as gas

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 30 mL dose)

Aluminum hydroxide 2400 mg 

(equivalent to dried gel, USP)

Magnesium hydroxide 2400 mg

Simethicone 240 mg

Purposes

OTC - PURPOSE SECTION

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

(equivalent to dried gel, USP)

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

Simethicone.......................................Antigas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-655-1505

How Supplied

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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

lidding-label
lidding-label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-619-12ML - Milliliter57896-619d6f80468-3173-4329-8a31-61efaafc3be912018-06-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66689-06166689-061-01, 66689-061-99
57896-619

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
ndc (product): 57896-619
591b9974-3356-4508-92a7-625282171ad36458dbb6-e433-4f28-bd5f-92986a7a89782023-12-11WarningsExact identifier
spl set id: 6458dbb6-e433-4f28-bd5f-92986a7a8978

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.