MAGNESIUM OXIDE- magnesium oxide tablet 
Safecor Health, 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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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 400 mg Robot Unit Dose Box Label
MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-302(NDC:0603-0209)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 174
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-302-10100 in 1 BOX, UNIT-DOSE09/30/201411/11/2019
1NDC:48433-302-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/30/201411/11/2019
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(48433-302)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287REPACK(48433-302)

Revised: 11/2019
Document Id: 283657c8-ccba-49aa-b6e8-aed017315c07
Set id: 640680ef-b856-467f-bbaf-1144b290d75d
Version: 2
Effective Time: 20191123
 
Safecor Health, LLC