NDC 0121-0527 Milk Of Magnesia
Magnesium Hydroxide Suspension Oral

Product Information

Milk Of Magnesia is a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Milk Of Magnesia is magnesium hydroxide. The product's dosage form is suspension and is administered via oral form.

Product Code0121-0527
Proprietary Name 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.
Milk Of Magnesia
Non-Proprietary Name 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.
Magnesium Hydroxide
Product Type 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.
Human Otc Drug
Dosage FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.
Pharmaceutical Associates, Inc.
Labeler Code0121
FDA Application Number 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.
part331
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-20-1982
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Milk Of Magnesia?


Product Characteristics

Color(s)WHITE (C48325)
Flavor(s)LEMON (C73396)

Product Packages

NDC 0121-0527-10

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

Product Details

What are Milk Of Magnesia Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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.
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • SUCROSE (UNII: C151H8M554)
  • FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • WATER (UNII: 059QF0KO0R)

Pharmacologic Class(es)

* Please review the disclaimer below.

Patient Education

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]

* Please review the disclaimer below.

Milk Of Magnesia Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



ANTACID/SALINE LAXATIVE

R04/14

pai
Pharmaceutical
Associates, Inc.

Greenville, SC 29605


Description



A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC).


Inactive Ingredients



A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC). Inactive Ingredients: Flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, silicone defoamer, sodium citrate, sodium saccharin, sodium salts of polymerized alkylnaphthalenesulfonic acid, sorbitol solution, and sucrose.

Sodium Content: 19 mg/10 mL.


Indications



For the temporary relief of heartburn, upset stomach, sour stomach, and/or acid indigestion.

For relief of occasional constipation. This product generally produces bowel movement in ½ to 6 hours.


Directions



Adults and children 12 years of age and over - Oral dosage is 5 mL (1 teaspoonful) with a little water up to four times daily or as directed by a physician. Children under 12 years of age - Consult a physician. SHAKE WELL BEFORE USING.

Drink a full glass (8 oz) of liquid following each dose. Adults and children 12 years of age and over - Oral dosage is 10 to 20 mL (2 to 4 teaspoonfuls); Children 6 to under 12 years of age - Oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls); Children 2 to under 6 years of age - Oral dosage is 5 mL (1 teaspoonful) or as directed by a physician. The dose may be taken as a single daily dose or in divided doses. Children under 2 years of age - Consult a physician. SHAKE WELL BEFORE USING.


Warnings



The maximum recommended daily dosage of this product is 20 mL (4 teaspoonfuls). Do not take more than this dosage in a 24-hour period or use this dosage for more than 2 weeks unless directed by a physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician. May have a laxative effect.

Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use longer than 1 week unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult your physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician.


Otc - Keep Out Of Reach Of Children



KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.


Drug Interaction Precaution



Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.


How Supplied



Milk of Magnesia Concentrate (white suspension-lemon flavored) is supplied in the following oral dosage form: NDC 0121-0527-10 (unit dose cups of 10 mL, 10 × 10's).


Storage



Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). PROTECT FROM FREEZING.


Principal Display Panel - 10 Ml Unit Dose Cup



Delivers 10 mL
NDC 0121-0527-10

MILK OF MAGNESIA
CONCENTRATE
Each 10 mL contains:
Magnesium Hydroxide 2400 mg.
Antacid, Saline Laxative
SHAKE WELL

FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F05271000


* Please review the disclaimer below.