Milk Of Magnesia
FDA Label NDC 24451-788

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llc Federal Solutions for the product Milk Of Magnesia (NDC 24451-788). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 15 mL tablespoonful)
Magnesium hydroxide 1200 mg

Otc - Purpose

Purpose
Saline laxative

Indications & Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings

Warnings

Otc - Ask Doctor

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 over 14 days

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug.
This product may interact with certain prescription drugs.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away.

Dosage & Administration

Directions

  • 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, in divided doses, or as directed by a doctor
  • drink a full glass (8 oz) of liquid with each dose


    • adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)
    children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
    children under 6 years: ask a doctor

Other Safety Information

Other information

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Inactive Ingredient

Inactive ingredients
purified water, sodium hypochlorite

Package Label.Principal Display Panel



———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30
MILK OF MAGNESIA
DELIVERS 30 mL
CONTAINING:
MAGNESIUM HYDROXIDE
2400 mg
SALINE LAXATIVE
ORIGINAL FLAVOR
SUGAR FREE
SHAKE WELL
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

Product Label (Product Label)

Product Label (Product Label)

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