FDA.reportPublic FDA data

milk of magnesia

Manufacturer
Natco Pharma USA LLC | GCP Laboratories
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:42

Label at a glance#

Productmilk of magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure10 sections

Indications and uses

As a Laxative relieves occasional constipation (irregularity) usually produces bowel movement in ½ 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, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older  30ml, not more than 60ml in 24 hrs  children under 12 years of age  ask a doctor

Storage and handling

Each tablespoonful {15ml} contains: magnesium 500mg Sodium Content: not more than 324ppm Store at room temperature, 20-25°C (68-77°F). Avoid freezing. Original flavor sugar free, dye free, alcohol free, gluten free Do not use if lid seal is open or damaged See top of cup for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient (in each 30 mL cup)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 2400 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

As a Laxative

  • relieves occasional constipation (irregularity)
  • usually produces bowel movement in ½ to 6 hours

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients

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

Ask a doctor or pharmacist before use if you are taking a prescription drug.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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, or as directed by a doctor
  • drink a full glass (8 oz) of liquid with each dose
adults and children 12 years and older 30ml, not more than 60ml in 24 hrs
 children under 12 years of age ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Each tablespoonful {15ml} contains: magnesium 500mg
  • Sodium Content: not more than 324ppm
  • Store at room temperature, 20-25°C (68-77°F). Avoid freezing.
  • Original flavor
  • sugar free, dye free, alcohol free, gluten free
  • Do not use if lid seal is open or damaged
  • See top of cup for lot number and expiration date

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

How SuppliedMilk of Magnesia, USP

HOW SUPPLIED SECTION

2400mg/30ml is a white to offwhite liquid supplied as follows:
NDC 69339-153-01
(1) unit dose cup                    30ml

NDC 69339-153-17
40 (4x10) unit dose cups       30ml

NDC 69339-153-19
100 (10x10) unit dose cups   30ml

Questions or comments?

OTC - QUESTIONS SECTION

201-786-6500

FOR INSTITUTIONAL USE ONLY

DASH

PHARMACEUTICALS

Distributed by: Dash Pharmaceuticals LLC

Upper Saddle RIver, NJ 07458

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 30 mL

NDC 69339-153-01

Milk of Magnesia, USP

2,400mg Magnesium Hydroxide/30mL

Shake Well

For Institutional Use Only

3 69339 15301 7

Lot# 123456

Exp: MM/YYYY

DASH Pharmaceuticals LLC

Upper Saddle River, NJ 07458

LD153.01.R0721

DASH-DOSE

milk of magnesia imagemilk of magnesia image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN4
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD4
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY4
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY4
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY4
253017milk of magnesia 8 % Oral SuspensionSY4
253017milk of magnesia 80 MG/ML Oral SuspensionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-153-01milk of magnesia30 mL in 1 CUP, UNIT-DOSESUSPENSION304
69339-153-17milk of magnesia40 in 1 BOX, UNIT-DOSESUSPENSION404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-153MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [NATCO PHARMA USA LLC]4Legacy NDC, 2 package rows20231102_e2a8f5b1-de24-4df8-901f-6daf5d241757.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-153-01ML - Milliliter69339-1539475c900-7feb-4fc1-9779-dc0e1fee232c12022-01-06
69339-153-17ML - Milliliter69339-153d731914f-e225-4e06-aff9-69a76701da8f12022-01-06

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69339-15369339-153-01, 69339-153-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
WATER059QF0KO0RIACT

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
4bc3038a-573b-40e4-909f-b67f30c0a1dbe2a8f5b1-de24-4df8-901f-6daf5d2417572023-11-01WarningsExact identifier
spl id: 4bc3038a-573b-40e4-909f-b67f30c0a1db
spl set id: e2a8f5b1-de24-4df8-901f-6daf5d241757

Reported adverse events (FAERS/openFDA)#

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