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NDC 63629-2217-01 Magnesium Oxide 253 mg/1 Details

Magnesium Oxide 253 mg/1

Magnesium Oxide is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-2217-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Magnesium Oxide

Product Information

NDC	63629-2217
Product ID	63629-2217_9be44461-e1a6-48f3-83e9-41576729aa7d
Associated GPIs	79400010360319
GCN Sequence Number	001409
GCN Sequence Number Description	magnesium oxide TABLET 420 MG ORAL
HIC3	C1H
HIC3 Description	MAGNESIUM SALTS REPLACEMENT
GCN	04093
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	253
Active Ingredient Units	mg/1
Substance Name	MAGNESIUM OXIDE
Labeler Name	Bryant Ranch Prepack
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	2023-12-31

Package

Package Images

NDC 63629-2217-01 (63629221701)

Pricing Information	N/A
NDC Package Code	63629-2217-1
Billing NDC	63629221701
Package	100 TABLET in 1 BOTTLE (63629-2217-1)
Marketing Start Date	2021-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 07274420-b7fe-4b68-aca5-867db8f22c07 Details

Active ingredient(s)

Magnesium Oxide

Purpose

Magnesium Oxide may help in magnesium deficiencies †

Use(s)

As a dietary supplement.

Warnings

Do not use

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.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

Directions

Take one tablet daily or as directed by a physician.

Other information

This product is sealed for your protection. Do not use if imprinted safety seal under cap is broken or missing.

Storage

Keep tightly closed and store in a cool, dry place.

Inactive ingredients

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

HOW SUPPLIED

NDC: 63629-2217-1: 100 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Magnesium Oxide 420 mgTablet, #100

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE

magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-2217(NDC:0603-0213)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	253 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	306
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-2217-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	11/10/2020

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-2217) , RELABEL(63629-2217)

Revised: 4/2022

Document Id: 9be44461-e1a6-48f3-83e9-41576729aa7d

Set id: 07274420-b7fe-4b68-aca5-867db8f22c07

Version: 101

Effective Time: 20220420