FDA Label for Milk Of Magnesia

View Indications, Usage & Precautions

Milk Of Magnesia Product Label

The following document was submitted to the FDA by the labeler of this product Natco Pharma Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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