FDA.reportPublic FDA data

Original Flavor Milk of Magnesia

Manufacturer
American Health Packaging
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:52:37

Label at a glance#

ProductMILK OF MAGNESIA ORIGINAL
Active ingredientMAGNESIUM HYDROXIDE
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) usually 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 1 unit dose cup (30 mL) to 2 unit dose cups (60 mL) children 6 to 11 years ½ unit dose cup (15 mL) to 1 unit dose cup (30 mL) children unde...

Storage and handling

each 30 mL cup contains: magnesium 1000 mg store at room temperature and avoid freezing DO NOT USE IF SEAL IS BROKEN This drug product is supplied in 30 ml unit dose cups as: 100 cups (10 x 10) ND 60687-429-76

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

  • relieves occasional constipation (irregularity)
  • usually produces bowel movement in 1/2 to 6 hours

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 14 days

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

  • 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,
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

  • 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

1 unit dose cup (30 mL) to 2 unit dose cups (60 mL)

children 6 to 11 years

½ unit dose cup (15 mL) to 1 unit dose cup (30 mL)

children under 6 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL cup contains: magnesium 1000 mg
  • store at room temperature and avoid freezing
  • DO NOT USE IF SEAL IS BROKEN
  • This drug product is supplied in 30 ml unit dose cups as:
    100 cups (10 x 10) ND 60687-429-76

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

PACKAGING INFORMATION

SPL UNCLASSIFIED SECTION

American Health Packaging unit dose cups (see Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows:
(2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649

Distributed by:
American Health Packaging
Columbus, OH 43217

8442972/0920F

Principal Display Panel – Tray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tray LabelTray Label

Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative

FOR INSTITUTIONAL USE ONLY

Store at room temperature
and avoid freezing.

8442972/0920F

Principal Display Panel – Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cup Label 2400 mg/30 mLCup Label 2400 mg/30 mL

NDC 60687- 429-45

Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative

2400 mg/30 mL
Delivers 30 mL

SHAKE WELL. AVOID FREEZING.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only

American Health Packaging
Columbus, OH 43217

0442972/0320

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN3
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD3
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY3
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY3
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY3
253017milk of magnesia 8 % Oral SuspensionSY3
253017milk of magnesia 80 MG/ML Oral SuspensionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00360687429458GTIN-14: 00360687429458
GTIN-12: 360687429458
UPC-A: 360687429458
EAN-13: 0360687429458
GTIN storage (14 digits): 00360687429458		Cup.jpg

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
60687-429-45MILK OF MAGNESIA ORIGINAL30 mL in 1 CUP, UNIT-DOSELIQUID303
60687-429-51MILK OF MAGNESIA ORIGINAL10 in 1 TRAYLIQUID103
60687-429-76MILK OF MAGNESIA ORIGINAL10 in 1 CASELIQUID103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-429-45ML - Milliliter60687-429572f36b6-dcac-479f-bf43-4cedef71468912021-02-05
60687-429-51ML - Milliliter60687-429569fc739-2221-47ab-b34f-a3242ae26d8f12021-02-05
60687-429-76ML - Milliliter60687-429fb89968f-997b-4adf-8057-b79f93c6a1c412021-02-05
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

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
60687-42960687-429-45, 60687-429-51, 60687-429-76
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
SODIUM HYPOCHLORITEDY38VHM5ODIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
ndc (package): 60687-429-76
ndc (package): 60687-429-45
ndc (package): 60687-429-51
ndc (product): 60687-429
ndc11 (package): 60687042976
ndc11 (package): 60687042951
ndc11 (package): 60687042945
spl id: 4e7cf85d-5c1f-4449-e063-6394a90a42de
spl set id: 7d7d789b-b2e7-4600-a025-0cd2ff5b3672
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
ndc (product): 57896-649

Reported adverse events (FAERS/openFDA)#

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