MAGNESIUM OXIDE by H. J. Harkins Company Inc. MAGNESIUM OXIDE tablet

MAGNESIUM OXIDE by

Drug Labeling and Warnings

MAGNESIUM OXIDE by is a Otc medication manufactured, distributed, or labeled by H. J. Harkins Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE 
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76519-1155
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76519-1155-6	60 in 1 CONTAINER; Type 0: Not a Combination Product	06/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/16/2017

Labeler - H. J. Harkins Company Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
H. J. Harkins Company Inc.		147681894	manufacture(76519-1155) , relabel(76519-1155) , repack(76519-1155)