MILK OF MAGNESIA- magnesium hydroxide suspension

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose)

Magnesium hydroxide 2400 mg

Purpose

Antacid / Saline Laxative

Uses  as Antacid

  relieves
     heartburn
     sour stomach
     acid indigestion
     and upset stomach associated with these symptoms

Uses as Saline Laxative

  for relief of occasional constipation (irregularity)
  this product generally produces bowel movement in 1/2  to 6 hours

Warnings for Antacid

Ask a doctor before use if you have

  kidney disease
  a magnesium-restricted diet

Ask a doctor or pharmacist before use If you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  do not take more than 60 mL (2 doses) in a 24-hour period
  do not use the maximum dosage for more than 2 weeks except under the advice and superision of a doctor
  may cause a laxative effect

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.

Warnings for Saline Laxative

Ask a doctor before use if you have

  kidney disease
  a magnesium-restricted diet
  abdominal pain, nausea, or vomiting
  a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use If you are

  presently 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 seriouscondition.
  you need to use a laxative for more that 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 for Antacid

  shake well before use
  mL=milliliters
  adults and children 12 years of age or older: 30 mL (1 dose) up to 2 times a day or as directed by a doctor
  children under 12 years of age: ask a doctor

Directions for Saline Laxative

  do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
  shake well before use
  mL=milliliters
  drink a full glass (8 oz) of liquid with each dose
  adults and children 12 years of age or older: 30 mL to 60 mL (1 to 2 doses)
  children under 12 years of age: ask a doctor
  the dose may be taken as a single daily dose or in divided doses

Other information for Antacid

  each 30 mL contains: magnesium 1 g
  store at 20° - 25°C (68° - 77°F)
  protect from freezing
  tamper-evident: do not use if seal on cup is missing or torn

Other information for Saline Laxative

  each 30 mL contains: magnesium 1 g
  store at 20° - 25°C (68° - 77°F)
  protect from freezing
  tamper-evident: do not use if seal on cup is missing or torn

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? call 1-800-845-8210

SPL UNCLASSIFIED SECTION

R03/25

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

MAJOR®

NDC: 0904-7564-62

Milk of Magnesia USP
Magnesium Hydroxide 2400 mg
Antacid / Saline Laxative

2400 mg/ 30 mL

 SHAKE WELL

Delivers 30 mL
See Drugs Facts Insert
For Institutional Use Only

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

F0431C300325

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7564
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	2400 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 4 (UNII: CZ227117JE)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
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
Color	white	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7564-73	10 in 1 CASE	01/08/2026
1		10 in 1 TRAY
1	NDC: 0904-7564-62	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	01/08/2026

Labeler - Major Pharmaceuticals (191427277)