FDA.reportPublic FDA data

Milk of Magnesia Liquid

Manufacturer
Major Pharmaceuticals
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:34:41

Label at a glance#

ProductMilk of Magnesia Liquid
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections

Indications and uses

•   relieves occasional constipation (irregularity) •   usually produces bowel movement in 1/2 hour 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 (8oz) of liquid with each dose  age dose Adults and children over 12 years of age 30  mL, not more than 60mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor

Storage and handling

• each 30 mL contains: magnesium 1000 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid seal is open or damaged​ • retain this insert for full product information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 2,400 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

SPL UNCLASSIFIED SECTION

•   relieves occasional constipation (irregularity)

•   usually produces bowel movement in 1/2 hour to 6 hours

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• kidney disease                                • a sudden change in bowel habits that lasts over 14 days

• a magnesium-restricted diet            • stomach pain, nausea, or vomiting

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking another medication.

This product may interact with certain medications.

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

SPL UNCLASSIFIED 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 (8oz) of liquid with each dose

 age

dose

Adults and children over 12 years of age

30  mL, not more than 60mL in 24 hrs

Children under 6 years of age

Do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: magnesium 1000 mg

• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

• do not use if lid seal is open or damaged​

• retain this insert for full product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, and sodium hypochlorite

OTC - QUESTIONS SECTION

Questions or comments? (855) 879-4368

SPL UNCLASSIFIED SECTION

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Re-order No.

701352

M-182

PI FG-20

Rev. 02/24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7327-62

Milk of Magnesia Liquid

2400 mg/30 mL

Saline Laxative

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Principal Display
Principal Display

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-7327-732025-09-05C16284748780-13b156c62-2d3f-fb37-e063-e6dba90a4e07Milk of Magnesia Liquid 2400 mg/30 mL
0904-7327-732025-07-29C16284748780-13b156c62-2d3f-fb37-e063-e6dba90a4e07Milk of Magnesia Liquid 2400 mg/30 mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7327-62ML - Milliliter0904-7327af37d313-ac62-46a6-86a7-ac6d7bdab7b412024-05-16
0904-7327-73ML - Milliliter0904-7327a7754712-d89c-4647-8706-ef6c706b955912024-05-16

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
0904-73270904-7327-62, 0904-7327-73

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
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT

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
0f758b73-1104-4b07-929d-a39733110dab1651197c-d39e-e512-e063-6394a90a7ee32025-09-05WarningsExact identifier
spl id: 0f758b73-1104-4b07-929d-a39733110dab
spl set id: 1651197c-d39e-e512-e063-6394a90a7ee3

Reported adverse events (FAERS/openFDA)#

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