MILK OF MAGNESIA CONCENTRATE- magnesium hydroxide suspension 
PAI Holdings, LLC

----------

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 over5 mL (1 teaspoonful)
children under 12 years of ageask 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 older15 mL to 30 mL
children under 12 yearsask a doctor

Other information

NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
dihydrate, sodium saccharin, sorbitol, and sucrose.

Questions or comments?

Call 1-800-845-8210

MANUFACTURED BY

Pharmaceutical
Associates, Inc.

Greenville, SC 29605
www.paipharma.com

R07/21

PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label

NDC 0121-0940-10

Milk of Magnesia Concentrate

Each 10 mL contains:

Magnesium Hydroxide 2400 mg.

ANTACID/ SALINE LAXATIVE

SHAKE WELL

Package Not Child-Resistant

See Insert

PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
MILK OF MAGNESIA CONCENTRATE 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0940
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorLEMON (LEMON-0IL) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0940-0010 in 1 CASE01/18/2022
110 in 1 TRAY
1NDC:0121-0940-1010 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 DrugM00701/18/2022
Labeler - PAI Holdings, LLC (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-0940)

Revised: 2/2022
Document Id: e521d5c6-0af8-4dc2-875e-5112fea8a10f
Set id: 2a99a1a8-a830-429f-9cfd-3f29c3d3547c
Version: 3
Effective Time: 20220203
 
PAI Holdings, LLC