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 Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 over: 5 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

• adults and children 12 years and older: 30 mL (2 TBSP) to 60 mL (4 TBSP)
• children 6 – 11 years: 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 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

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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

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0431
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
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
Color	white	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0431-30	10 in 1 CASE	09/04/1979
1		10 in 1 TRAY
1		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 final	part331	09/04/1979

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0431)