MILK OF MAGNESIA- magnesium hydroxide liquid

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by RIJ Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 15 mL Tablespoon)

Magnesium Hydroxide 1200 mg

Purpose

Saline laxative

Use

• relieves occasional constipation (irregularity).
• This product 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 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 one 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

• 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
• mL = milliliter, TBSP = Tablespoonful

• adults and children 12 years and older:

  30 mL (2 TBSP) to 60 mL (4 TBSP)

• children 6 to 11 years:

  15 mL (1 TBSP) to 30 mL (2 TBSP)

• children under 6 years:

  ask a doctor

Other information

• TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
• Store at room temperature 15º - 30ºC (59º - 86ºF)
• keep tightly closed
• keep from freezing
• each tablespoon (15 mL) contains: magnesium 498 mg
• each tablespoon (15 mL) contains: sodium 3 mg

Inactive ingredients

citric acid, purified water, sodium hypochlorite

Principal Display Panel

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-125
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-125-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-125-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
3	NDC: 53807-125-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/16/1999

Labeler - RIJ Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
RIJ Pharmaceutical Corporation		144679156	manufacture(53807-125)