MILK OF MAGNESIA- magnesium hydroxide suspension 
Pharmaceutical Associates, 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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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 over5 to 15 mL (1 to 3 teaspoonfuls)
children under 12 years of ageask 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 older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 yearsask a doctor

Other information

NDC 0121-0431-30:30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

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

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

NDC 0121-0431-30

Milk of Magnesia USP
ANTACID/ SALINE LAXATIVE

Each 30 mL contains:

Magnesium Hydroxide
2400 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)
[See USP Controlled Room Temperature].

Protect from freezing.

10 x 30 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

T0431300318
R03/18

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0431
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0431-3010 in 1 CASE09/04/1979
110 in 1 TRAY
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 finalpart33109/04/1979
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0431)

Revised: 6/2018
Document Id: 6e5d14e7-9f01-2eea-e053-2a91aa0a55e8
Set id: 2de868a0-c652-473c-8b61-636083b7f757
Version: 3
Effective Time: 20180611
 
Pharmaceutical Associates, Inc.