Magnesium Oxide

Magnesium Oxide
SPL v3
SPL
SPL Set ID 0bb322a5-fb92-14de-e063-6294a90a4c1b
Route
ORAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (400 mg)
Inactive Ingredients
Stearic Acid Silicon Dioxide Croscarmellose Sodium Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: C14 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Magnesium Oxide Tablets

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Magnesium Oxide Tablets

Uses
  • relieves
  • acid indigestion
  • upset stomach
Section 42229-5

MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet

Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Magnesium Oxide Tablets

Warnings

Ask a doctor if you have

kidney disease

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

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

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 11/23 AA

Principal Display Panel

NDC 10135-0786-62

Magnesium Oxide

400 mg

120 TABLETS

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

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


Structured Label Content

Uses (USES)
  • relieves
  • acid indigestion
  • upset stomach
Section 42229-5 (42229-5)

MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet

Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Magnesium Oxide Tablets

Purpose

Antacid

Warnings (WARNINGS)

Ask a doctor if you have

kidney disease

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

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

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 11/23 AA

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0786-62

Magnesium Oxide

400 mg

120 TABLETS

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (In each tablet))

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Ask A Doctor Or Pharmacist Before Use If You Are (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


Advanced Ingredient Data


Raw Label Data

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