Magnesium Hydroxide/Aluminum Hydroxice/Simethicone

Manufacturer
Cardinal Health 107, LLC
Effective date
2022-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:02:43

Label at a glance#

ProductMagnesium Hydroxide/Aluminum Hydroxice/Simethicone
Active ingredientALUMINUM HYDROXIDE, DIMETHICONE, MAGNESIUM HYDROXIDE
Label structure12 sections

Indications and uses

Uses - acid indigestion - heartburn - sour stomach - upset stomach due to these symptoms - pressure and bloating commonly referred to as gas

Dosage and administration

Directions - do not exceed the maximum recommended daily dose in a 24 hour period - shake well before use - do not use the maximum daily dose for more than 2 weeks Age (yr) Dose (mL) adults and children 12 years and over 30 mL, not more than 60 mL in 24 hrs. children under 12 years ask a doctor

Storage and handling

- store at 20-25°C (68-77°F) - protect from excessive moisture - see bottom of cup for lot number and expiration date Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L57472900222

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each 30 mL Contains: Purpose

  1. Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg Antacid
  2. Magnesium hydroxide USP 2400 mg Antacid
  3. Simethicone Max 240 mg Antigas

Delivers 30 mL

Shake Well

See Insert

  • Sugar Free - Dye Free - Alcohol Free
  • each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 1000 mg

Purpose

OTC - PURPOSE SECTION

Antacid / Antigas

Indications and Usage

INDICATIONS & USAGE SECTION

Uses

- acid indigestion

- heartburn

- sour stomach

- upset stomach due to these symptoms

- pressure and bloating commonly referred to as gas

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

- kidney disease

- a magnesium-restricted diet

Stop use and ask a doctor if

- you have symptoms that last for more than 2 weeks.

Ask Doctor/Pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

- do not exceed the maximum recommended daily dose in a 24 hour period

- shake well before use

- do not use the maximum daily dose for more than 2 weeks

Age (yr)

Dose (mL)

adults and children 12 years and over

30 mL, not more than 60 mL in 24 hrs.

children under 12 years

ask a doctor

Warnings

WARNINGS SECTION

For Institutional Use Only

Keep Out of Reach of Children

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 right away. (1-800-222-1222)

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xanthan gum

Storage and Handling

STORAGE AND HANDLING SECTION

- store at 20-25°C (68-77°F)

- protect from excessive moisture

- see bottom of cup for lot number and expiration date

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor's NDC Number

Distributed By:

Cardinal Health

Dublin, OH 43017

L57472900222

Product Insert
Product Insert

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magnesium Hydroxide 2400 mg

Aluminum Hyroxide 2400 mg

Simethicone Max 240 mg

5 cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6839-73ML - Milliliter0904-683987c05ade-8a4d-487c-b24d-1b50225d8b4d12020-04-20

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
55154-355755154-3557-5
0904-6839

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aedc2398-0f82-4ccc-bb6a-6f722d443a44959b548e-597e-48ca-afed-04e56e44ca982023-03-14WarningsExact identifier
spl set id: 959b548e-597e-48ca-afed-04e56e44ca98

Reported adverse events (FAERS/openFDA)#

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