LEADER MILK OF MAGNESIA- magnesium hydroxide suspension

leader milk of magnesia by

Drug Labeling and Warnings

leader milk of magnesia by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL)

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

• do not exceed the maximum recommended daily dose in a 24 hour period
• shake well before use
• 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
• mL = milliliter

• adults and children 12 years and older:

  30 mL to 60 mL

• children 6 to 11 years:

  15 mL to 30 mL

• children under 6 years:

  ask a doctor

Other information

• each 15 mL contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg
• does not meet USP requirements for preservative effectiveness
• store at 20-25°C (68-77°F)
• close cap tightly after use
• avoid freezing

Inactive ingredients

light mineral oil, peppermint oil, purified water, saccharin sodium

Questions or comments?

1-800-719-9260

Principal Display Panel

Genuine

Milk of Magnesia

Magnesium Hydroxide, 1200 mg per 15 mL

Saline Laxative

COMPARE TO PHILLIPS’® MILK OF MAGNESIA active ingredient

Fresh Mint Flavor

Sugar-Free

Stimulant-Free

Cramp-Free

100% Money Back Guarantee

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

LEADER MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0483
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PEPPERMINT OIL (UNII: AV092KU4JH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0483-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/20/2019

Labeler - Cardinal Health (097537435)