MILK OF MAGNESIA CONCENTRATE- magnesium hydroxide suspension

Milk of Magnesia Concentrate by

Drug Labeling and Warnings

Milk of Magnesia Concentrate by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 over: 5 mL (1 teaspoonful)
• children under 12 years of age: ask 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 older: 15 mL to 30 mL
• children under 12 years: ask a doctor

Other information

• each teaspoonful (5 mL) contains: magnesium 1000 mg
• Sodium Content: 19 mg/10 mL
• store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
• Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

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

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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

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA CONCENTRATE 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0940
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 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor	LEMON (LEMON-0IL)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0940-00	10 in 1 CASE	01/18/2022
1		10 in 1 TRAY
1	NDC: 0121-0940-10	10 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	01/18/2022

Labeler - PAI Holdings, LLC (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	manufacture(0121-0940)