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 LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 15 mL tablespoonful)
Magnesium hydroxide 1200 mg

PURPOSE

Purpose
Saline laxative

INDICATIONS & USAGE

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 1/2 to 6 hours

WARNINGS

Warnings

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug.
This product may interact with certain prescription drugs.

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)
children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
children under 6 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

• each 15 mL tablespoonful contains: magnesium 500 mg
• store at room temperature and avoid freezing
• close cap tightly after use

INACTIVE INGREDIENT

Inactive ingredients
purified water, sodium hypochlorite

PRINCIPAL DISPLAY PANEL

———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30
MILK OF MAGNESIA
DELIVERS 30 mL
CONTAINING:
MAGNESIUM HYDROXIDE
2400 mg
SALINE LAXATIVE
ORIGINAL FLAVOR
SUGAR FREE
SHAKE WELL
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24451-788(NDC:0904-0788)
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)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24451-788-30	100 in 1 BOX
1		30 mL in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/12/2013

Labeler - LLC Federal Solutions (965036895)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(24451-788)