MAGNESIUM OXIDE- magnesium oxide tablet 
A&Z Pharmaceutical, Inc.

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

ACTIVE INGREDIENT (IN EACH TABLET)

Magnesium Oxide 400 mg (241.3 mg elemental magnesium)

PURPOSE

Antacid

USES

relieves ■ acid indigestion ■ upset stomach

WARNINGS

Ask a doctor before use 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.

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

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 controlled room temperature 59-86 °F (15-30 °C) ■ do not use if imprinted safety seal under cap is broken or missing ■ Magnesium content per tablet: 240mg

Inactive ingredients

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

DISPLAY PANEL

picture of carton
MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-174
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 174
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62211-174-9922200 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/03/200305/05/2015
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705manufacture(62211-174)

Revised: 5/2015
Document Id: 048effe3-95f0-43ff-b0b1-ff64f7721429
Set id: 41b5ba82-6c41-4406-a12d-2c1e01ab4036
Version: 2
Effective Time: 20150505
 
A&Z Pharmaceutical, Inc.