Magnesium Oxide

Magnesium Oxide

Drug Labeling and Warnings

Drug Details

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MAGNESIUM OXIDE- magnesium oxide tablet 
Method Pharmaceuticals, 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

Drug Facts

Active ingredient

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

Purpose

Antacid

Use

relieves: ■ acid indigestion ■ upset stomach

Warnings

Ask a doctor before use if

  • you have kidney disease
  • you are taking a prescription drug (antacids may interact with certain prescription drugs)
  • you are pregnant or breast feeding.

Do not take more than 2 tablets in a 24 hour period.

  • May have a laxative effect.

Keep out of reach of children.

Directions

  • take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

Other information

  • Store at controlled room temperature 15° to 30°C (59° to 86°F).
  • Tamper evident, do not use if imprinted safety seal under cap is broken or missing.

Inactive ingredients

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Questions?

Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088

Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118

Rev. 04/18

Principal Display Panel

NDC: 58657-120-12
Magnesium Oxide
400 mg
241.3 Elemental Magnesium
Antacid
120 Tablets

NDC: <a href=58657-120-12 Magnesium Oxide 400 mg 241.3 Elemental Magnesium Antacid 120 Tablets " src="https://fda.report/DailyMed/0af63651-f9d9-43b9-b6f0-4878466a82e6/magnesium-oxide-01.jpg&archiveid=335040"/>

MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58657-120
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58657-120-12120 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33107/25/2018
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 7/2018
 
Method Pharmaceuticals, LLC


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