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 FREDS, INC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 1/2 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 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.

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 over: 2 to 4 tablespoonfuls
• children 6 years to 11 years: 1 to 2 tablespoonsfuls
• children under 6 years: ask a doctor

Other information

• each tablespoon contains: magnesium 500 mg
• do not freeze
• store at room temperature tightly closed

Inactive ingredients

purified water, sodium hypochlorite

package Label

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-649
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
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-649-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012
2	NDC: 55315-649-26	769 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/01/2012

Labeler - FREDS, INC (005866116)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(55315-649) , pack(55315-649)