MEDIBEST MILK OF MAGNESIA- magnesium hydroxide liquid

Medibest Milk of Magnesia by

Drug Labeling and Warnings

Medibest Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Purine Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 15 mL Tablespoon) Purpose

Magnesium hydroxide 1200 mg...............…………..........Saline laxative

PURPOSE

Saline laxative

Use

Use relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ to 6 hours.

WARNINGS

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 over 14 days

Ask a doctor or pharmacist before use if you are

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.

Directions

● 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.

● mL = milliliter; TBSP = Tablespoon

• 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 SAFETY INFORMATION

Other information

● each tablespoon (15 mL) contains: magnesium 500 mg

● each tablespoon (15 mL) contains: Sodium 3mg

● store at room temperature and avoid freezing.  Close cap tightly after use.

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, purified water, sodium hypochlorite

QUESTIONS

Questions or comments? 1-800-403-5328 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIBEST MILK OF MAGNESIA 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58599-058
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58599-058-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/12/2016

Labeler - Purine Pharma LLC (019950491)

Registrant - Purine Pharma LLC (019950491)

Establishment
Name	Address	ID/FEI	Business Operations
Purine Pharma LLC		019950491	manufacture(58599-058)