STRATUSCARE MILK OF MAGNESIA SUGAR FREE- magnesium hydroxide suspension 
Stratus Pharamceuticals

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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Stratuscare Milk of Magnesia Sugar Free

Drug Facts

Active ingredient (in each 15 mL tablespoon)

Magnesium hydroxide 1200mg

Purpose

Saline Laxative

Uses

  • relieves occasional constipation (irregularity)
  • 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 last more than 2 weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. This may indicate 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 immediately.

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
  • TBSP = tablespoonful
adults and children 12 years and older2 to 4 TBSP
children 6 to 11 years1 to 2 TBSP
children under 6 yearsask a doctor

Other information

  • each tablespoon (15 mL) contains: magnesium 501mg and sodium 2mg
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
  • keep tightly closed

Inactive ingredients

purified water, sodium hypochlorite

Questions or comments?

800-442-7882

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

STRATUSCARE

Milk of Magnesia

NDC 58980-440-85

Magnesium Hydroxide /
Saline Laxative

  • Effective overnight relief
  • Stimulant & cramp free
  • Low sodium

Distributed by:
STRATUS
PHARMACEUTICALS INC

SUGAR
FREE

12 FL OZ (355 mL)

Compare to Phillips'® Milk of Magnesia
active ingredient‡‡

Principal Display Panel - 355 mL Bottle Label
STRATUSCARE MILK OF MAGNESIA SUGAR FREE 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) 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:58980-440-85355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/201405/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/26/201405/27/2014
Labeler - Stratus Pharamceuticals (789001641)

Revised: 10/2017
Document Id: d1e226ce-c754-4d95-8108-40fc682b9c88
Set id: 1a49445c-5729-4032-baa9-5a612d30ac5d
Version: 2
Effective Time: 20171026
 
Stratus Pharamceuticals