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NDC 71610-0182-60 Magnesium Oxide 400 mg/1 Details

Magnesium Oxide 400 mg/1

Magnesium Oxide is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is MAGNESIUM OXIDE.

MedlinePlus Drug Summary

Magnesium is an element your body needs to function normally. Magnesium oxide may be used for different reasons. Some people use it as an antacid to relieve heartburn, sour stomach, or acid indigestion. Magnesium oxide also may be used as a laxative for short-term, rapid emptying of the bowel (before surgery, for example). It should not be used repeatedly. Magnesium oxide also is used as a dietary supplement when the amount of magnesium in the diet is not enough. Magnesium oxide is available without a prescription.

Related Packages: 71610-0182-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Magnesium Oxide

Product Information

NDC	71610-0182
Product ID	71610-182_1c7508c2-75cf-41b4-9172-89f4e7054368
Associated GPIs	48400020000310
GCN Sequence Number	078687
GCN Sequence Number Description	magnesium oxide TABLET 400 MG ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	45064
HICL Sequence Number	000609
HICL Sequence Number Description	MAGNESIUM OXIDE
Brand/Generic	Generic
Proprietary Name	Magnesium Oxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	MAGNESIUM OXIDE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0182-60 (71610018260)

Pricing Information	N/A
NDC Package Code	71610-182-60
Billing NDC	71610018260
Package	90 TABLET in 1 BOTTLE (71610-182-60)
Marketing Start Date	2018-10-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 11b2ce71-61fd-4e75-a859-a260b1dda080 Details

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. May have a laxative effect.

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 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: 240 mg

INACTIVE INGREDIENTS

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	400 mg
90	71610-182-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20181107JH

PRINCIPAL DISPLAY PANEL - 400 mg

NDC 71610-182 - Magnesium Oxide 400 mg - Rx Only

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE

magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-182(NDC:0603-0209)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (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:71610-182-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	12/03/2003

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-182)

Revised: 11/2018

Document Id: 1c7508c2-75cf-41b4-9172-89f4e7054368

Set id: 11b2ce71-61fd-4e75-a859-a260b1dda080

Version: 1

Effective Time: 20181107