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 Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Magnesium hydroxide 400 mg

Purpose

Saline laxative

INDICATIONS & USAGE

Uses

As an Antacid:

• heartburn
• upset/sour stomach
• acid indigestion

As a Laxative (usually within ½ to 6 hours):

• occasional constipation (irregularity)

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

• Age: Dose
• adults and children 12 years of age and over: 5 mL to 15 mL (1 to 3 teaspoonfuls)
• children under 12 years of age: ask 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

• Age: Dose
• adults and children 12 years and older: 30 mL (2 TBSP) to 60 mL (4 TBSP)
• children 6 to 11 years of age: 15 mL (1 TBSP) to 30 mL (2 TBSP)
• children under 6 years: ask a doctor

Other information

• each teaspoonful (5 mL) contains: magnesium 400 mg
• store at 20°C to 25°C (68°F to 77°F).
• Avoid freezing
• Protect from light
• Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms:

NDC: 81033-014-30: 30 mL unit-dose cup

NDC: 81033-014-52: Case containing 100 unit-dose cups of 30 mL each.

Inactive ingredients

cherry flavor, fumed silica, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum

Questions or comments?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

PIS-014-V01

Rev. 09/2025

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

NDC: 81033-014-52

Milk of Magnesia, USP 2400 mg per 30 mL

Delivers 30 mL

Case = 100 UD Cups

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-014
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	400 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SILICA (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (Milky-White)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-014-52	100 in 1 CASE	09/23/2025
1	NDC: 81033-014-30	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	09/04/1979

Labeler - Kesin Pharma Corporation (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		117447816	label(81033-014) , pack(81033-014)