Milk Of Magnesia Suspension
FDA Label NDC 63739-196

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Corporation Dba Sky Packaging for the product Milk Of Magnesia (NDC 63739-196). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, as an antacid, as a laxative (usually within ½ to 6 hours), ask a doctor before use if you have, stop use and ask a doctor if, as a laxative, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ As An Antacid

→ As A Laxative (usually Within ½ To 6 Hours)

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask A Doctor If

→ As A Laxative

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 30 Ml Cup Tray Label

Active Ingredient (In Each 5 Ml)

Magnesium hydroxide 400 mg

Purpose

Saline laxative

As An Antacid

heartburn
upset/sour stomach
acid indigestion

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 (Usually Within ½ To 6 Hours)

occasional constipation (irregularity)

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

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

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 63739-196.01

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.