Magnesium Oxide by Bryant Ranch Prepack MAGNESIUM OXIDE tablet

Magnesium Oxide by

Drug Labeling and Warnings

Magnesium Oxide by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

Purpose

Antacid

Use

relieves: ■ acid indigestion ■ upset stomach

Warnings

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.

Directions

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

Other information

• 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.

Questions?

Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088

Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118

Rev. 04/18

HOW SUPPLIED

NDC: 63629-9420-1: 120 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Magnesium Oxide 400mg

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE 
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-9420(NDC:58657-120)
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-9420-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	07/25/2018

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-9420) , RELABEL(63629-9420)