MAGNESIUM OXIDE- magnesium oxide tablet 
H. J. Harkins Company 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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Active Ingredient

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Purpose

relieves:

acid indigestion
upset stomach

KEEP OUT OF REACH OF CHILDREN

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.

Dosage and Administration

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

Storage & Handling

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.

Indications & Usage

Antacid

Warnings

Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect. If pregnant or breast-feeding, ask a health professional before use.

Pregnancy or Breast Feeding

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

Keep Out of Reach of Children

Package Label. Prinicpal Display Panel

76519 1155.jpg

MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1155
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
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76519-1155-660 in 1 CONTAINER; Type 0: Not a Combination Product06/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/16/2017
Labeler - H. J. Harkins Company Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H. J. Harkins Company Inc.147681894manufacture(76519-1155) , relabel(76519-1155) , repack(76519-1155)

Revised: 12/2017
Document Id: 60bb4830-207a-17eb-e053-2a91aa0a60ae
Set id: 60bb4830-2079-17eb-e053-2a91aa0a60ae
Version: 1
Effective Time: 20171219
 
H. J. Harkins Company Inc.