NDC 0121-0431 Milk Of Magnesia

Magnesium Hydroxide

NDC Product Code 0121-0431

NDC CODE: 0121-0431

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.

NDC Code Structure

  • 0121 - Pharmaceutical Associates, Inc.

NDC 0121-0431-30

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Milk Of Magnesia with NDC 0121-0431 is a 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.

Labeler Name: Pharmaceutical Associates, Inc.

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 400 mg/5mL

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.

  • HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SORBITOL (UNII: 506T60A25R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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.
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 09-04-1979 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’.

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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

Other

ANTACID/SALINE LAXATIVE

Otc - Purpose

A suspension of magnesium hydroxide. Each 5 mL (1 teaspoonful) contains 400 mg of magnesium hydroxide and provides not less than 10 mEq/5 mL of acid-neutralizing capacity (ANC).

Inactive Ingredients

Flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, silicone defoamer, sodium saccharin, and sorbitol solution.

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 to 15 mL (1 to 3 teaspoonfuls) 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 30 to 60 mL (2 to 4 tablespoonfuls); Children 6 to under 12 years of age - Oral dosage is 15 to 30 mL (1 to 2 tablespoonfuls); Children 2 to under 6 years of age - Oral dosage is 5 to 15 mL (1 to 3 teaspoonfuls) 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 60 mL (12 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 USP (white suspension, spearmint flavor) is supplied in the following oral dosage form: NDC 0121-0431-30 (unit dose cups of 30 mL, 10 × 10's).

Storage

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

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