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Magnesium Oxide by Safecor Health, LLC

Dosage form: tablet
Ingredients: MAGNESIUM OXIDE 400mg
Labeler: Safecor Health, LLC
NDC Code: 48433-302

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.

Magnesium Oxide Tablets

ACTIVE INGREDIENTS

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purposes

Antacid

USES

Relieves: acid indigestion, upset stomach

WARNINGS

Do Not Use

Do not take more than 2 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a physician. May have a laxative effect.

Ask a Doctor if you have:

Kidney disease

Ask a Doctor/Pharmacist before use if you are:

Taking a prescription drug. Antacids may interact with certain prescription drugs.

Pregnancy or Breast Feeding

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

Keep Out of Reach of Children

DIRECTIONS

Antacid Directions: take 1 tablet twice a day or as directed by a physician

Magnesium Supplement Directions: take 1 to 2 tablets daily or as directed by a physician

OTHER INFORMATION

store at room temperature 59°-86° F (15°-30°C) , Magnesium content per tablet: 240 mg

INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL
MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-302(NDC:0603-0209)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SILICON DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code174
Contains    
Packaging
#Item CodePackage Description
1NDC:48433-302-10100 POUCH in 1 BOX, UNIT-DOSE
1NDC:48433-302-011 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/30/2014
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC828269675REPACK(48433-302)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC078805287REPACK(48433-302)

 
Safecor Health, LLC

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Medically reviewed on Jul 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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