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.

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MILK OF MAGNESIA

CONCENTRATE

Drug Facts

Active ingredient (in each 10 mL)

Magnesium hydroxide 2400 mg

Purpose

Saline laxative

Uses

As an Antacid

•
heartburn
•
upset/sour stomach
•
acid indigestion

As a Laxative

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

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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 of 20 mL 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 mL (1 teaspoonful)

children under 12 years of age

ask a doctor

As a Laxative

•
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.
•
mL = milliliter

adults and children 12 years and older

15 mL to 30 mL

children under 12 years

ask a doctor

Other information

•
each teaspoonful (5 mL) contains: magnesium 1000 mg
•
Sodium Content: 19 mg/10 mL
•
store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
•
Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

NDC 0121-0527-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

antifoam af emulsion, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, sodium salts of polymerized alkylnaphthalenesulfonic acid, sorbitol, and sucrose.

Questions or comments?

Call 1-800-845-8210

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Distributed by:
Cardinal Health

Dublin, OH 43017

L33755081020

R03/18

Principal Display Panel

Milk of Magnesia Concentrate

5 Cups

bag label
MILK OF MAGNESIA 
milk of magnesia suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9412(NDC:0121-0527)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PYRROBUTAMINE NAPHTHALENE DISULFONATE (UNII: 144X0H6HW6)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9412-55 in 1 BAG06/07/201112/30/2022
110 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 finalpart33106/07/201112/30/2022
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 12/2022
Document Id: ca59f73b-4948-4c7a-8f4a-06efa292e4a1
Set id: 04e7f807-8d79-4836-8efa-d874cbf4d2e2
Version: 9
Effective Time: 20221222
 
Cardinal Health 107, LLC