NDC 69339-153 Milk Of Magnesia

Magnesium Hydroxide

NDC Product Code 69339-153

NDC CODE: 69339-153

Proprietary Name: Milk Of Magnesia 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 Hydroxide 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 used for a short time to treat occasional constipation. It is a laxative (osmotic-type) that is thought to work by drawing water into the intestines, an effect that helps to cause movement of the intestines. This medication is also used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.

Product Characteristics


NDC Code Structure

  • 69339 - Dash Pharmaceuticals Llc

NDC 69339-153-17

Package Description: 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 30 mL in 1 CUP, UNIT-DOSE (69339-153-01)

NDC Product Information

Milk Of Magnesia with NDC 69339-153 is a a human over the counter drug product labeled by Dash Pharmaceuticals Llc. The generic name of Milk Of Magnesia is magnesium hydroxide. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 253017.

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.

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.

  • WATER (UNII: 059QF0KO0R)

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: Dash Pharmaceuticals Llc
Labeler Code: 69339
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: 12-27-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

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 30 Ml Cup)

Magnesium hydroxide 2400 mg


Saline laxative


  • As a Laxativerelieves occasional constipation (irregularity)usually produces bowel movement in ½ to 6 hours

Ask A Doctor Before Use If You Have

  • Kidney diseasea magnesium-restricted dietstomach pain, nausea, or vomitinga sudden change in bowel habits that lasts over 14 days

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug.

This product may interact with certain prescription drugs.

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).


  • Shake well before use do not exceed the maximum recommended daily dose in a 24-hour period dose may be taken once a day preferably at bedtime, or as directed by a doctor drink a full glass (8 oz) of liquid with each doseadults and children 12 years and older 30ml, not more than 60ml in 24 hrs children under 12 years of age ask a doctor

Other Information

  • Each tablespoonful {15ml} contains: magnesium 500mgSodium Content: not more than 324ppmStore at room temperature, 20-25°C (68-77°F). Avoid freezing.Original flavorsugar free, dye free, alcohol free, gluten freeDo not use if lid seal is open or damagedSee top of cup for lot number and expiration date

Inactive Ingredient

Purified water, sodium hypochlorite

How Suppliedmilk Of Magnesia, Usp

2400mg/30ml is a white to offwhite liquid supplied as follows:NDC 69339-153-01(1) unit dose cup                    30mlNDC 69339-153-1740 (4x10) unit dose cups       30mlNDC 69339-153-19100 (10x10) unit dose cups   30ml

* Please review the disclaimer below.