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

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

NDC: 71335-1960-1: 60 Tablets in a BOTTLE

NDC: 71335-1960-2: 30 Tablets in a BOTTLE

NDC: 71335-1960-3: 90 Tablets in a BOTTLE

NDC: 71335-1960-4: 100 Tablets in a BOTTLE

NDC: 71335-1960-5: 120 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Magnesium Oxide 400 mg Tablet

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE 
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1960(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: 71335-1960-1	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2021
2	NDC: 71335-1960-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2021
3	NDC: 71335-1960-3	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2021
4	NDC: 71335-1960-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2021
5	NDC: 71335-1960-5	120 in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2021

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(71335-1960) , RELABEL(71335-1960)