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Milk of Magnesia by Pharmaceutical Associates, Inc.

Medically reviewed on June 11, 2018

Dosage form: suspension
Ingredients: MAGNESIUM HYDROXIDE 400mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0431

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 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
  • 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:
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

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (4000 MPA.S) 
METHYLPARABEN 
POTASSIUM CITRATE 
PROPYLENE GLYCOL 
WATER 
CYCLOMETHICONE 4 
PROPYLPARABEN 
SORBITOL 
SACCHARIN SODIUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0431-3010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
130 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/04/1979
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0431)

 
Pharmaceutical Associates, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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