Milk of Magnesia

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 400 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

As an Antacid

SPL UNCLASSIFIED SECTION

• heartburn
• upset/sour stomach
• acid indigestion

As a Laxative (usually within ½ to 6 hours)

SPL UNCLASSIFIED SECTION

• occasional constipation (irregularity)

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• kidney disease
• a magnesium-restricted diet
• stomach pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use If you aretaking a prescription drug. This product may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

As an Antacid

SPL UNCLASSIFIED SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

STORAGE AND HANDLING SECTION

• 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:

Overbagged with 5 x 30 mL unit dose cup in each bag, NDC 55154-9403-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L33325170526

F0431300721

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-9403-5

MILK OF MAGNESIA USP

5 CUPS

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Milk of Magnesia
• magnesium hydroxide
• MAGNESIUM CATION
• HYDROXIDE ION
• HYPROMELLOSE 2910 (4000 MPA.S)
• METHYLPARABEN
• POTASSIUM CITRATE
• PROPYLENE GLYCOL
• PROPYLPARABEN
• WATER
• CYCLOMETHICONE 4
• SACCHARIN SODIUM
• SORBITOL

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.