FDA.reportPublic FDA data

MILK OF MAGNESIA ORIGINAL

Manufacturer
TYA Pharmaceuticals
Effective date
2012-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:40:46

Label at a glance#

ProductMILK OF MAGNESIA ORIGINAL
Active ingredientMAGNESIUM HYDROXIDE
Label structure8 sections

Indications and uses

relieves occasional constipation (irregularity) generally 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

• magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use • each 15 mL tablespoonful contains: TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

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)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

• kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days taking a prescription drug. This product may interact with certain prescription drugs. • 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 ask a health professional before use.

Ask a doctor before use if you have




Ask a doctor or pharmacist before use if you are



Stop use and ask a doctor if



If pregnant or breast-feeding,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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

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


TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN2
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD2
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY2
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY2
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY2
253017milk of magnesia 8 % Oral SuspensionSY2
253017milk of magnesia 80 MG/ML Oral SuspensionSY2

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0649-12020-01-31C16284748780-19d75b9d0-bd0d-f424-e053-dadaa90a57ce04245f2b-56c5-4d2f-bb77-de96d3579070

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0649-1MILK OF MAGNESIA ORIGINAL16 mL in 1 BOTTLELIQUID162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0649MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_04245f2b-56c5-4d2f-bb77-de96d3579070.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8382
SODIUM HYPOCHLORITEINACTIVE INGREDIENTDY38VHM5OD2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64725-064964725-0649-1
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
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
WATER059QF0KO0RIACT
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 · 1 matching rows.

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

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
0b22d1e4-6b18-48b1-890e-9d2c147f0acc04245f2b-56c5-4d2f-bb77-de96d35790702012-05-02WarningsExact identifier
spl id: 0b22d1e4-6b18-48b1-890e-9d2c147f0acc
spl set id: 04245f2b-56c5-4d2f-bb77-de96d3579070

Reported adverse events (FAERS/openFDA)#

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