FDA.reportPublic FDA data

MILK OF MAGNESIA ORIGINAL

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2024-07-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:58:45

Label at a glance#

ProductMILK OF MAGNESIA ORIGINAL
Active ingredientMAGNESIUM HYDROXIDE
Label structure8 sections

Indications and uses

• relieves occasional constipation (irregularity) • usually produces bowel movement in 1/2 to 6 hours

Dosage and administration

• shake well before use • do not exceed the maximum recommended daily dose in a 24 hour period • 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 adults and children 12 years and older 2 to 4 tablespoonfuls children 6 to 11 years 1 to 2 tablespoonfuls children under 6 years ask a doctor

Storage and handling

• each 15 mL tablespoonful contains: magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL tablespoonful)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 1200 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • usually produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

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.

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

  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • 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

adults and children 12 years and older

2 to 4 tablespoonfuls

children 6 to 11 years

1 to 2 tablespoonfuls

children under 6 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite
Relabeled By: Preferred Pharmaceuticals Inc.

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Milk of Magnesia
Milk of Magnesia

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8413MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [PREFERRED PHARMACEUTICALS INC.]2Unmatched20240719_eecae5f9-a49c-4a8f-8611-d9e235087ce6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8413-3ML - Milliliter68788-84136a424c18-33dc-4612-a245-9767aa11927b12023-06-06
57896-649-10ML - Milliliter57896-6490c99c2ec-bbbd-487e-8321-9526927acb2212025-12-16
57896-649-12ML - Milliliter57896-6492b4815f9-8e78-4461-afe8-860d734e34db12018-04-19
57896-649-16ML - Milliliter57896-649b6606945-3d87-4f74-8615-797d50c0700512013-03-03
57896-649-28ML - Milliliter57896-6496ba7d4ee-7438-419b-8a56-f97c7c8dfc0812018-11-06

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-841368788-8413-3
57896-649

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
MAGNESIUM HYDROXIDENBZ3QY004SACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
ndc (product): 57896-649
cf82a7c4-cd77-4d25-a993-154244811e8aeecae5f9-a49c-4a8f-8611-d9e235087ce62025-08-12WarningsExact identifier
spl set id: eecae5f9-a49c-4a8f-8611-d9e235087ce6

Reported adverse events (FAERS/openFDA)#

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