MILK OF MAGNESIA- milk of magnesia suspension 
Cardinal Health 107, 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.

----------

Milk of Magnesia

Drug Facts

Active ingredient (in each 5 mL)

Magnesium hydroxide 400 mg

Purpose

Saline laxative

Uses

As an Antacid

heartburn
upset/sour stomach
acid indigestion

As a Laxative (usually within ½ to 6 hours)

occasional constipation (irregularity)

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 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

As an Antacid

do not exceed the maximum recommended daily dose in a 24 hour period
shake well before use
can be taken with water
mL = milliliter

adults and children 12 years of age and over

5 to 15 mL (1 to 3 teaspoonfuls)

children under 12 years of age

ask a doctor

As a Laxative

do not exceed the maximum recommended daily dose of 60 mL 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.
mL = milliliter; TBSP = Tablespoon

adults and children 12 years and older

30 mL (2 TBSP) to 60 mL (4 TBSP)

children 6 – 11 years

15 mL (1 TBSP) to 30 mL (2 TBSP)

children under 6 years

ask a doctor

Other information

each teaspoonful (5 mL) contains: magnesium 400 mg
store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:

Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9403-5.

Inactive ingredients

flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.

Questions or comments?

Call 1-800-845-8210

MANUFACTURED BY
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed by:

Cardinal Health

Dublin, OH 43017

L33325171020

Principal Display Panel

Milk of Magnesia USP

5 Cups

bag label
MILK OF MAGNESIA 
milk of magnesia suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9403(NDC:0121-0431)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9403-55 in 1 BAG06/07/2011
130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/07/2011
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 12/2022
Document Id: 4fa1bcbd-0ca8-4d23-bbdb-7f7716fcb3d4
Set id: 144c7242-4ff9-404a-86bf-48e2871eb0cd
Version: 10
Effective Time: 20221222
 
Cardinal Health 107, LLC