MILK OF MAGNESIA- magnesium hydroxide suspension 
Western Family Foods Inc

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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Western Family Milk Of Magnesia Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide 1200 mg

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 lasts 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. 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 (1-800-222-1222).

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
•
for accurate dosing, use dose cup provided
•
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 information

•
each tablespoon (15 mL) contains: calcium 20 mg and magnesium 595 mg
•
does not meet USP requirements for preservative effectiveness
•
store at 20º-25ºC (68º-77ºF)
•
close cap tightly after use
•
avoid freezing

Inactive ingredient

purified water

Principal Display Panel

Milk of Magnesia

SALINE LAXATIVE

MAGNESIUM HYDROXIDE

Gluten Free

Comfortable Cramp Free Relief

Sugar Free

Stimulant Free

Original Flavor

COMPARE TO PHILLIPS’® MILK OF MAGNESIA Active Ingredient

12 FL OZ (355 mL)

03472-E-PER

Milk of Magnesia Front Label
Milk of Magnesia Back Label
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-396
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)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-396-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/199205/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/04/199205/21/2018
Labeler - Western Family Foods Inc (192166072)

Revised: 3/2018
Document Id: e0caa8da-5004-485f-8fc9-85be93bcc617
Set id: eea6d600-ad69-495d-b387-49b55105727d
Version: 3
Effective Time: 20180329
 
Western Family Foods Inc