Milk Of Magnesia
FDA Label NDC 69339-153

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natco Pharma Usa Llc for the product Milk Of Magnesia (NDC 69339-153). 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 active ingredient (in each 30 ml cup), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking a prescription drug., stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 30 Ml Cup)

Magnesium hydroxide 2400 mg

Purpose

Saline laxative

Uses

As a Laxative

  • relieves occasional constipation (irregularity)
  • usually 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 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).

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, or as directed by a doctor
  • drink a full glass (8 oz) of liquid with each dose
    • adults 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 500mg
  • Sodium Content: not more than 324ppm
  • Store at room temperature, 20-25°C (68-77°F). Avoid freezing.
  • Original flavor
  • sugar free, dye free, alcohol free, gluten free
  • Do not use if lid seal is open or damaged
  • See 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                    30ml

NDC 69339-153-17
40 (4x10) unit dose cups       30ml

NDC 69339-153-19
100 (10x10) unit dose cups   30ml

Questions Or Comments?

201-786-6500

FOR INSTITUTIONAL USE ONLY

DASH

PHARMACEUTICALS

Distributed by: Dash Pharmaceuticals LLC

Upper Saddle RIver, NJ 07458

Principal Display Panel

Delivers 30 mL

NDC 69339-153-01

Milk of Magnesia, USP

2,400mg Magnesium Hydroxide/30mL

Shake Well

For Institutional Use Only

3 69339 15301 7

Lot# 123456

Exp: MM/YYYY

DASH Pharmaceuticals LLC

Upper Saddle River, NJ 07458

LD153.01.R0721

DASH-DOSE

Milk Of Magnesia Image (Dash Milk Of Magnesium)

Milk Of Magnesia Image (Dash Milk Of Magnesium)

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