FDA.reportPublic FDA data

Milk of Magnesia

Manufacturer
A-S Medication Solutions
Effective date
2021-03-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:49:52

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure12 sections

Indications and uses

heartburn upset/sour stomach acid indigestion occasional constipation (irregularity)

Dosage and administration

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 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 d...

Storage and handling

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 0121-0431-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

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 are taking 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 over5 to 15 mL (1 to 3 teaspoonfuls)
children under 12 years of ageask 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 older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 yearsask 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:
NDC 0121-0431-30:30 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

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2887

NDC: 50090-2887-0 10 mL in a TRAY / 10 in a CASE

Magnesium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2887-02023-02-07C16284748780-1f386c64a-44e9-0266-e053-dadaa90a7c1aMilk of Magnesia
50090-2887-02023-01-30C16284748780-1f386c64a-44e9-0266-e053-dadaa90a7c1aMilk of Magnesia

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0431-30ML - Milliliter0121-04318f8054f2-185a-40d8-992f-43c890584ab412014-10-03

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-288750090-2887-0
0121-0431

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
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 MagnesiaMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2de868a0-c652-473c-8b61-636083b7f7572026-01-22WarningsExact identifier
ndc (product): 0121-0431
4b3c09c7-13f9-45db-9d4e-b42b8637e364601401a4-2578-4acf-aa47-ee65afe58ef72023-02-06WarningsExact identifier
spl set id: 601401a4-2578-4acf-aa47-ee65afe58ef7

Reported adverse events (FAERS/openFDA)#

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