NDC 0904-6757 Milk Of Magnesia

Magnesium Hydroxide

NDC Product Code 0904-6757

NDC 0904-6757-14

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Milk Of Magnesia with NDC 0904-6757 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Milk Of Magnesia is magnesium hydroxide. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Milk Of Magnesia 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 HYDROXIDE 1200 mg/15mL

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.

  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

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: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-15-1991 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: 12-31-2020 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.

Information for Patients

Magnesium Hydroxide

Magnesium Hydroxide is pronounced as (mag nee' zee um) (hye drox' ide)

Why is magnesium hydroxide medication prescribed?
Magnesium hydroxide is used on a short-term basis to treat constipation.This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more inf...
[Read More]

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Milk Of Magnesia Product Label Images

Milk Of Magnesia 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 (In Each 15 Ml)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

  • •relieves occasional constipation (irregularity) •generally produces bowel movement in ½ to 6 hours

Ask A Doctor Before Use If You Have

  • •kidney disease •a magnesium-restricted diet •stomach pain, nausea, or vomiting •a sudden change in bowel habits that lasts more than 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If

  • •you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. •you need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •do not exceed the maximum recommended daily dose in a 24 hour period •shake well before use •dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor •drink a full glass (8 oz) of liquid with each dose •for accurate dosing, use dose cup provided •mL = milliliteradults and children 12years and older30 mL to 60 mLchildren 6 to 11 years15 mL to 30 mLchildren under 6 yearsask a doctor

Other Information

  • •each 15 mL contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg •does not meet USP requirements for preservative effectiveness •store at 20-25°C (68-77°F) •close cap tightly after use •avoid freezing

Inactive Ingredients

Light mineral oil, peppermint oil, purified water, saccharin sodium

* Please review the disclaimer below.