MAGNESIUM OXIDE- magnesium oxide tablet 
Bryant Ranch Prepack

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

Other information

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

HOW SUPPLIED

NDC: 63629-9420-1: 120 Tablets in a BOTTLE

Magnesium Oxide 400mg

Label
MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-9420(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)  
MICROCRYSTALLINE CELLULOSE (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:63629-9420-1120 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/25/2018
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-9420) , RELABEL(63629-9420)

Revised: 6/2023
Document Id: 945f34e6-993b-4a7d-b457-66f96b676c3f
Set id: 77fa8fe5-33ac-44b2-9596-5b276e9f2162
Version: 103
Effective Time: 20230616
 
Bryant Ranch Prepack