Magnesium Oxide by APNAR PHARMA LP / INVAHEALTH INC / APNAR PHARMA LLP MAGNESIUM OXIDE tablet

Magnesium Oxide by

Drug Labeling and Warnings

Magnesium Oxide by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, INVAHEALTH INC, APNAR PHARMA LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet)

Magnesium Oxide 400 mg (241.3 mg elemental magnesium)

PURPOSE

Purpose

Antacid

INDICATIONS & USAGE

Uses

relieves

• acid indigestion
• upset stomach

WARNINGS

Warnings

Ask a doctor before use if you have kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacid 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 advice and supervision of a physician

If pregnant or breast-feeding, ask a professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions

Antacid Directions: take 1 tablet twice a day or as directed by a physician

Magnesium Supplement Directions: take 1 or 2 tablets day or as directed by a physician

STORAGE AND HANDLING

Other information

• Magnesium content per tablet : 241.3 mg
• store at controlled room temperature 59°- 86°F ( 15°- 30°C)
• do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, maize starch

QUESTIONS

Questions or comments?

1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 04/2022

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

PRINCIPAL DISPLAY PANEL

NDC: 24689-132-01

Magnesium Oxide Tablets 400 mg

241.3 mg elemental Magnesium per tablet

Dietary supplement, Antacid

120 Tablets

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE 
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-132
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to off white)	Score	2 pieces
Shape	ROUND (Round shaped standard concave)	Size	11mm
Flavor		Imprint Code	AM3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-132-01	120 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	08/05/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
INVAHEALTH INC		116840615	pack(24689-132) , label(24689-132)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-132) , analysis(24689-132) , pack(24689-132)