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 VistaPharm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

saline laxative/antacid

DESCRIPTION

Active Ingredient

(in each 5 mL = 1 teaspoonful)

Magnesium Hydroxide.................400 mg

Inactive Ingredients

anhydrous citric acid, benzyl alcohol, methylparaben, propylene glycol, propylparaben, purified water.

FOR USE AS A LAXATIVE

INDICATIONS

Uses

• For relief of occasional constipation (irregularity)
• This product generally produces bowel movement in 1/2 to 6 hours.

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 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 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 (1-800-222-1222) right away.

DIRECTIONS

• shake well before use
• drink a full glass (8 oz) of liquid with each dose
• mL = milliliter

• Adults and children 12 years of age and older: 30 mL to 60 mL
• Children 6 to 11 years of age: 15 mL to 30 mL
• Children under 6 years of age:

  Consult a

  physician.

or as directed by a physician.

• The dose may be taken as a single daily dose or in divided doses.

FOR USE AS AN ANTACID

INDICATIONS

Uses

For the relief of

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

WARNINGS

Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician

May have laxative effect

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.

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 (1-800-222-1222) right away.

DIRECTIONS

• shake well before use
• mL = milliliter
• adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician
• do not take more than 12 teaspoonfuls (60 mL) in 24-hour period
• do not use the maximum dosage for more than 2 weeks
• children under 12 years: consult a physician

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

HOW SUPPLIED

Milk of Magnesia USP 400 mg/5 mL is a white opaque liquid supplied as follows:

NDC: 66689-053-01: 30 mL unit-dose cup

NCD 66689-053-99: Case contains 100 unit-dose cups of 30 mL (NDC: 66689-053-01), packaged in 10 trays of 10 unit-dose cups each.

STORAGE

Other Information

• Protect from freezing
• Store at 20° to 25°C (68° to 77°F)

Questions or Comments?

Call 1-888-655-1505 (toll-free)

SPL UNCLASSIFIED SECTION

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

VP2152R1

09/17

PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

Milk of Magnesia,  USP

2,400 mg Magnesium Hydroxide per 30 mL

Delivers 30 mL

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F).

Shake Well

XACTDOSETM

Manufactured by:
VistaPharm, Inc.
Largo, FL 33771, USA

VP2153R2

01/18

NDC: 66689-053-01

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66689-053
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		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66689-053-99	10 in 1 CASE	04/19/2018
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	04/19/2018

Labeler - VistaPharm, Inc. (116743084)