MILK OF MAGNESIA- magnesium hydroxide suspension

milk of magnesia by

Drug Labeling and Warnings

milk of magnesia by is a Otc medication manufactured, distributed, or labeled by Natco Pharma USA LLC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients

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

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69339-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	2400 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69339-153-17	40 in 1 BOX, UNIT-DOSE	12/27/2021
1	NDC: 69339-153-01	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	12/27/2021

Labeler - Natco Pharma USA LLC (079590418)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(69339-153)