NDC 63629-1126 Magnesium Oxide

Magnesium Oxide

NDC Product Code 63629-1126

NDC CODE: 63629-1126

Proprietary Name: Magnesium Oxide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Magnesium Oxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
120
Score: 1

NDC Code Structure

  • 63629 - Bryant Ranch Prepack

NDC 63629-1126-1

Package Description: 120 TABLET in 1 BOTTLE

NDC Product Information

Magnesium Oxide with NDC 63629-1126 is a a human over the counter drug product labeled by Bryant Ranch Prepack. The generic name of Magnesium Oxide is magnesium oxide. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bryant Ranch Prepack

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Magnesium Oxide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM OXIDE 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
FDA Application Number: part331 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-25-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Magnesium Oxide Product Label Images

Magnesium Oxide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Purpose

Antacid

Use

Relieves: ■ acid indigestion ■ upset stomach

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.

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-1088Manufactured for:


Method Pharmaceuticals, LLC


Fort Worth, Texas 76118


Rev. 04/18

How Supplied

NDC: 63629-1126-1 120 tablets in a BOTTLE

* Please review the disclaimer below.