Milk of Magnesia

Manufacturer
Cardinal Health 107, LLC
Effective date
2022-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:02:41

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure9 sections

Indications and uses

Uses - relieves occasional constipation (irregularity) - generally produces bowel movement in ½ to 6 hours

Dosage and administration

Shake Well - each 10 mL contains : calcium 40 mg, sodium 35 mg, and magnesium 1000 mg Sugar Free - Dye Free - Alcohol Free Directions - 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 Age (yr) Dose (mL) adults and childr...

Storage and handling

- store at 20-25°C (68-77°F) - protect from excessive moisture - do not use if lid seal is open or damaged - see bottom of cup for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 10 mL cup)

Magnesium Hydroxide 2400 mg.

Purpose

OTC - PURPOSE SECTION

Saline Laxative

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Shake Well

- each 10 mL contains: calcium 40 mg, sodium 35 mg, and magnesium 1000 mg

Sugar Free - Dye Free - Alcohol Free

Directions

- 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

Age (yr)

Dose (mL)

adults and children 12 years and over

10 mL, not more than 20 mL in 24 hours

children under 12 years

ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xantham gum

Indications and Usage

INDICATIONS & USAGE SECTION

Uses

- relieves occasional constipation (irregularity)

- generally produces bowel movement in ½ to 6 hours

Storage and Handling

STORAGE AND HANDLING SECTION

- store at 20-25°C (68-77°F)

- protect from excessive moisture

- do not use if lid seal is open or damaged

- see bottom of cup for lot number and expiration date

Keep Out of Reach of Children

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. (1-800-222-1222)

Warnings

WARNINGS SECTION

For Institutional Use Only

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 taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

___________________________________________________________________

Stop use and ask a doctor if

- you have rectal bleeding or no bowel movements 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.

Distributed By:

Cardinal Health

Dublin, OH 43017

L57472741221

Instructions For Use

INSTRUCTIONS FOR USE SECTION

Milk of Magnesia Concentrated 2400 mg / 10 mL

SPL UNCLASSIFIED SECTION

Insert
Insert

Milk of Magnesia Concentrated 10 mL Major Pharmaceutical OTC Monograph

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  1. Milk of Magnesia Concentrate
  2. 2400 mg /10 mL
  3. Magnesium Hydroxide 2400 mg
  4. 5 Cups
  5. bag labelbag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6840-72ML - Milliliter0904-68409a249871-c95a-4725-8e11-fa73122c75ba12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-355555154-3555-5
0904-6840

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48022a50-eb48-4c51-8e87-32e75e0a9cf237c6fc11-76c3-4740-8bd7-d09a52e4af772023-03-20WarningsExact identifier
spl set id: 37c6fc11-76c3-4740-8bd7-d09a52e4af77

Reported adverse events (FAERS/openFDA)#

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