MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE- magnesium hydroxide,aluminum hydroxice,simethicone suspension 
Major Pharmaceuticals

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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Major Pharmaceuticals
Unit dose OTC Monograph drugs
MgOH-Al-OH-Simethicone

Magnesium hydroxide, Aluminum hydroxide, Simethicone 1200/1200/120 mg per 30 mL
Major Pharmaceutical OTC Monograph

701031 1200/1200/120 Mg/30 mLNDC 0904-6838-73

Each 30 mL Contains:

Magnesium Hydroxide1200 mg

Aluminum Hydroxide 1200 mg

Simethicone 120 mg

Delivers 30 mL

Shake Well

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

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 120 mL in 24 hours

children under 12 years

ask a doctor

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

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)

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

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 presecription drug. Antacids may interact with certain prescription drugs.

___________________________________________________________________

Stop use and ask a doctor if

- you have symptoms that last more than 2 weeks

___________________________________________________________________

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

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

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

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

Uses

- acid indigestion

- heartburn

- sour stomach

- upset stomach due to these symptoms

- pressure and bloating commonly referred to as gas

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

Active ingredient (in each 30 mL cup)

Magnesium hydroxide USP 1200 mg

Magnesium hydroxide USP 1200 mg

Simethicone 120 mg

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

Antacid

Antacid

Antigas

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

Other information

- each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 500 mg

- store at 20-25°C (68-77°F)

- protect from excessive moisture

- do not use if lid seal is open or damaged

- sugar free, dye free, alcohol free

- see bottom of cup for lot number and expiration date

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

701031 IFU

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Major Pharmaceutical OTC Monograph

701032 LidNDC 0904-6839-73

Each 30 mL Contains:

Magnesium Hydroxide 2400 mg

Aluminum Hydroxide 2400 mg

Simethicone 240 mg

Max

Delivers 30 mL

Shake Well

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

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

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

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)

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

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. Antacids may interact with certain prescription drugs.

___________________________________________________________________

Stop use and ask a doctor if

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

___________________________________________________________________

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

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

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

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

Uses

- acid indigestion

- heartburn

- sour stomach

- upset stomach due to these symptoms

- pressure and bloating commonly referred to as gas

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

Antacid

Antacid

Antigas

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

Other information

- each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 1000 mg

- store at 20-25°C (68-77°F) -

- protect from excessive moisture

- do not use if lid seal is open or damaged -

- sugar free, dye free, alcohol free

- see bottom of cup for lot number and expiration date

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

701032 IFU

MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
magnesium hydroxide,aluminum hydroxice,simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6839
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 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 CPS) (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:0904-6839-7310 in 1 CASE12/27/2019
110 in 1 TRAY
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 finalpart33112/27/2019
MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
magnesium hydroxide/aluminum hydroxice/simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6838
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE120 mg  in 30 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1200 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLCELLULOSE (15 CPS) (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:0904-6838-7310 in 1 CASE12/27/2019
110 in 1 TRAY
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 finalpart33112/27/2019
Labeler - Major Pharmaceuticals (191427277)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(0904-6838, 0904-6839)

Revised: 11/2019
Document Id: 97a1dba8-d8ff-3e7d-e053-2a95a90aa4c5
Set id: 97978a75-bf85-ba66-e053-2995a90a3b2d
Version: 1
Effective Time: 20191117
 
Major Pharmaceuticals