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 5 mL) One teaspoonful)

Magnesium Hydroxide 400 mg

Purpose

Saline laxative/Antacid

Use

Laxative

• relieves occasional constipation (irregularity).
• generally produces bowel movement in ½ to 6 hours.

Antacid

• relieves acid indigestion, sour stomach, heartburn.

Warnings

Ask a doctor before use if you have

• kidney disease
• stomach pain, nausea or vomiting
• notice a sudden change in bowel habits that persists over a period of 2 weeks
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacid may interact with certain prescription drugs.

When using this product

• it may have a laxative effect
• do not exceed the maximum recommended daily dosgae in a 24-hour period

Stop use and ask a doctor if

Laxative

• you have rectal bleeding or failure to have a bowel movement after use. These may indicate a serious condition.
• you need to use a laxative for more than one week

Antacid

• symptoms last for more than 2 weeks.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

• shake well before use

	Laxative use:	Antacid use
	Do not use dosage cup for ages under 12 years. Follow each dose with a full glass (8 oz) of liquid.	Do not use dosage cup. Follow each dose with a little water.
adults and children 12 years and older	2-4 TBSP (30-60 mL) once a day	1-3 tsp (5-15 mL) up to 4 times a day
6 to 11 years	1-2 TBSP (15-30 mL) once a day	ask a doctor
2 to 5 years	1-3 tsp (5-15 mL) once a day	ask a doctor
under 2 years	ask a doctor	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 teaspoon (5 mL) contains: magnesium 166 mg
• each teaspoon (5 mL) contains: sodium 1 mg

Inactive ingredients

citric acid, flavor, 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: 53807-401
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	400 mg  in 5 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	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-401-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-401-16	473 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(53807-401)