RxNorm Names

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LEADER MILK OF MAGNESIA (magnesium hydroxide) liquid
[Cardinal Health]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4f1bd366-4270-47f6-9ce9-ca1c93bde06d

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient (in each 15 mL TBSP)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

•: relieves occasional constipation (irregularity)
•: generally produces bowel movement in ½ to 6 hours

Warnings

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 more than 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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, in divided doses, or as directed by a doctor
•: drink a full glass (8 oz) of liquid with each dose
•: for accurate dosing, use dose cup provided
•: TBSP = tablespoonful

adults and children 12 years and older	2 to 4 TBSP.
children 6 to 11 years	1 to 2 TBSP.
children under 6 years	ask a doctor

Other information

•: each tablespoon (15 mL) contains: calcium 20 mg, magnesium 595 mg, potassium 2 mg and sodium 2 mg
•: does not meet USP requirements for preservative effectiveness
•: store at 20-25ºC (68-77ºF)
•: keep tightly closed

Inactive ingredients

anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Phillips’® Milk of Magnesia active ingredient

Milk of Magnesia

Saline Laxative

Magnesium Hydroxide

Comfortable, Cramp Free Relief

Stimulant Free

Wild Cherry Flavor

ALCOHOL 0.4%

LEADER MILK OF MAGNESIA
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-459
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION)	MAGNESIUM HYDROXIDE	1200 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 28
GLYCERIN
WATER
SORBITOL
SUCROSE
XANTHAN GUM

Product Characteristics
Color	PINK (Opaque Light pink)	Score
Shape		Size
Flavor	CHERRY (wild cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:37205-459-40	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/19/2005

Labeler - Cardinal Health (097537435)

Revised: 01/2013

Document Id: 88dc17a3-ffbf-4063-891b-fd8083a9fdd9

Set id: 4f1bd366-4270-47f6-9ce9-ca1c93bde06d

Version: 3

Effective Time: 20130114

Cardinal Health

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