FDA.reportPublic FDA data

Magnesium Hydroxide

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:54

Label at a glance#

ProductMagnesium Hydroxide
Active ingredientMAGNESIUM HYDROXIDE
Label structure9 sections

Indications and uses

Laxative : relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours. Antacid : relieves heartburn, sour stomach & acid indigestion.

Dosage and administration

Laxative : ° shake well before using ° drink a full glass (8 ounces) of liquid with each dose ° may be taken as a single or divided dose Antacid: ° do not take more than 12 teaspoons in 24 hours ° do not use maximum dosage for more than 2 weeks Laxative: adults and children 12 years and older: 2 to 4 tablespoons children 6 to under 12 years: 1 to 2 tablespoons children 2 to under 6 years: 1 to 3 teaspoons children...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium Hydroxide 400mg

Purpose

OTC - PURPOSE SECTION

Saline Laxative / Antacid

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.

Uses

INDICATIONS & USAGE SECTION

Laxative: relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours.

Antacid: relieves heartburn, sour stomach & acid indigestion.

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 2 weeks

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

° antacids may interact with certain prescription drugs ° laxatives may affect how other drugs work, so should be taken 2 or more hours before or after other drugs.

When using this product as an antacid, it may have a laxative effect.

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 ° symptoms last more than 2 weeks.

If pregnant or breast-feeding, ask a health professional before use.

Other Information

SPL UNCLASSIFIED SECTION

each 5 mL teaspoon contains: magnesium 165mg and sodium 2 mg

store at room temperature

protect from freezing

keep tightly closed

Directions

DOSAGE & ADMINISTRATION SECTION

Laxative: ° shake well before using

° drink a full glass (8 ounces) of liquid with each dose

° may be taken as a single or divided dose

Antacid: ° do not take more than 12 teaspoons in 24 hours

° do not use maximum dosage for more than 2 weeks

Laxative:

adults and children 12 years and older: 2 to 4 tablespoons

children 6 to under 12 years: 1 to 2 tablespoons

children 2 to under 6 years: 1 to 3 teaspoons

children under 2 years: ask a doctor

Antacid:

adults and children 12 years and older: 1 to 3 teaspoons with water, up to 4 times daily

children under 12 years: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, purified water, saccharin sodium, sodium hypochlorite

Questions or comments? Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Milk of MagnesiaMilk of Magnesia

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN1
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD1
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY1
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY1
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY1
253017milk of magnesia 8 % Oral SuspensionSY1
253017milk of magnesia 80 MG/ML Oral SuspensionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-903-162019-09-24C16284748780-1934fe258-49e9-48b1-e053-8cdaa90a720aMilk of Magnesia Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-903-16Magnesium Hydroxide473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-903MAGNESIUM HYDROXIDE LIQUID [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110502_c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-903-16ML - Milliliter21695-9036c416b7f-e8db-49f6-8922-d5ca55f6777a12012-07-24
0536-2470-83ML - Milliliter0536-2470623ee23f-15f4-4c81-ae10-2791bb685d0512013-02-13
0536-2470-85ML - Milliliter0536-2470eb3f4864-2ee5-43b4-a0dd-b030377e0aa612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S1
MAGNESIUM HYDROXIDEACTIVE MOIETYNBZ3QY004S1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM HYPOCHLORITEINACTIVE INGREDIENTDY38VHM5OD1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
21695-90321695-903-16
0536-2470

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIM
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYPOCHLORITESODIUM HYPOCHLORITEDY38VHM5ODSUSPENSION / ORAL3 mg/1mlExact identifier — unii+route
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form

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 MINTMAGNESIUM HYDROXIDERugby Laboratories5fd89979-903e-4b31-872d-3b8974af3a6b2026-02-09WarningsExact identifier
ndc (product): 0536-2470
c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710c29995d6-e8f2-4e7b-aa03-6ce5aa0e77102011-02-21WarningsExact identifier
spl id: c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710
spl set id: c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710

Reported adverse events (FAERS/openFDA)#

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