MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet

Marlex Pharmaceuticals, 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 Tablets

ACTIVE INGREDIENT (In each tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid

USES

relieves
acid indigestion upset stomach

WARNINGS

Ask a doctor if you have

kidney disease

Ask a doctor or 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 advise 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

Magnesium content per tablet: 241.3mg
store at room temperature 59°-86° F (15°-30°C)
do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

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

Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in the U.S.A.

Rev. 02/19AH

PRINCIPAL DISPLAY PANEL

NDC 10135-0583-62
Magnesium Oxide
400 mg
120 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0583-62
Magnesium Oxide
400 mg
120 TABLETS

MAGNESIUM OXIDE
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10135-583
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	174
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10135-583-62	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	02/01/2019

Labeler - Marlex Pharmaceuticals Inc (782540215)