MEDIBEST MILK OF MAGNESIA- magnesium hydroxide liquid 
Purine Pharma LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medibest Milk of Magnesia

Drug Facts

Active ingredient (in each 15 mL Tablespoon) Purpose

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

Saline laxative

Use

Use relieves occasional constipation (irregularity). This product usually 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 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 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

● 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.

● mL = milliliter; TBSP = Tablespoon

adults and children 12 years and older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 yearsask a doctor

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 ingredients: Citric acid, purified water, sodium hypochlorite

Questions or comments? 1-800-403-5328 

image description

MEDIBEST MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58599-058-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/12/2016
Labeler - Purine Pharma LLC (019950491)
Registrant - Purine Pharma LLC (019950491)
Establishment
NameAddressID/FEIBusiness Operations
Purine Pharma LLC019950491manufacture(58599-058)

Revised: 9/2016
Document Id: ceb5bd07-10c8-410b-accb-6aafa72bcb35
Set id: f3600e72-fa94-4dbe-bf41-259b5398d9d5
Version: 1
Effective Time: 20160912
 
Purine Pharma LLC