LEADER MILK OF MAGNESIA - magnesium hydroxide liquid
Cardinal Health

Disclaimer: 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.

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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. This may indicate 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
store at 20º-25ºC (68º-77ºF)
keep tightly closed

Inactive ingredients

anhydrous citric acid, D&C red no. 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

Overnight Relief

Stimulant Free

Wild Cherry Flavor

ALCOHOL 0.4%

Milk of Magnesia Front Label

Milk of Magnesia Back Label

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 HYDROXIDE)	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	Multilevel Packaging
1	NDC:37205-459-40	355 mL in 1 BOTTLE	None

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: 11/2011 Cardinal Health