Mag Hydroxide-Alum Hydroxide-Simethicone Max Unit dose OTC Monograph drugs

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone by

Drug Labeling and Warnings

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE- magnesium hydroxide,aluminum hydroxice,simethicone suspension 
Cardinal Health 107, LLC

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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Mag Hydroxide-Alum Hydroxide-Simethicone Max

Unit dose OTC Monograph drugs

Active Ingredient

Each 30 mL Contains: Purpose

  •   Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg Antacid
  •   Magnesium hydroxide USP 2400 mg Antacid
  •   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

Antacid / Antigas

Indications and Usage

Uses

- acid indigestion

- heartburn

- sour stomach

- upset stomach due to these symptoms

- pressure and bloating commonly referred to as gas

Ask Doctor

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

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

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

Warnings

For Institutional Use Only

Keep Out of Reach of Children

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

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

Inactive Ingredients

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

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

Product Insert

Principal Display Panel

Magnesium Hydroxide 2400 mg

Aluminum Hydroxide 2400 mg

Simethicone Max 240 mg

5 cups

bag label
MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
magnesium hydroxide,aluminum hydroxice,simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55154-3557(NDC: 0904-6839)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 mg  in 30 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (Suspension) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55154-3557-55 in 1 BAG12/27/201912/27/2019
130 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 finalpart33112/27/201912/27/2019
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 3/2023