FDA.reportPublic FDA data

Milk of Magnesia

Manufacturer
McKesson Corporation dba SKY Packaging
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:56:44

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections

Indications and uses

heartburn upset/sour stomach acid indigestion occasional constipation (irregularity)

Dosage and administration

do not exceed the maximum recommended daily dose in a 24 hour period shake well before use can be taken with water mL = milliliter adults and children 12 years of age and over 5 to 15 mL (1 to 3 teaspoonfuls) children under 12 years of age ask a doctor do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period shake well before use dose may be taken once a day preferably at bedtime, in divided d...

Storage and handling

each teaspoonful (5 mL) contains: magnesium 400 mg store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing. Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form: NDC 63739-196.01 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 400 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

As an Antacid

SPL UNCLASSIFIED SECTION

  • heartburn
  • upset/sour stomach
  • acid indigestion

As a Laxative (usually within ½ to 6 hours)

SPL UNCLASSIFIED SECTION

  • occasional constipation (irregularity)

Warnings

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

As an Antacid

SPL UNCLASSIFIED SECTION

  • do not exceed the maximum recommended daily dose in a 24 hour period
  • shake well before use
  • can be taken with water
  • mL = milliliter
adults and children 12 years of age and over5 to 15 mL (1 to 3 teaspoonfuls)
children under 12 years of ageask a doctor

As a Laxative

SPL UNCLASSIFIED SECTION

  • do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
  • shake well before use
  • 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.
  • mL = milliliter; TBSP = Tablespoon
adults and children 12 years and older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each teaspoonful (5 mL) contains: magnesium 400 mg
  • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
  • Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:
NDC 63739-196.0130 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63739-196-01

Milk of Magnesia USP
ANTACID, SALINE LAXATIVE

Each 30 mL contains:

Magnesium Hydroxide
2400 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

 Memphis, TN 38141       

                                                   F0431C300923F0431C300923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN9
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD9
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY9
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY9
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY9
253017milk of magnesia 8 % Oral SuspensionSY9
253017milk of magnesia 80 MG/ML Oral SuspensionSY9

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
63739-196-01Milk of Magnesia30 mL in 1 CUP, UNIT-DOSESUSPENSION309
63739-196-10Milk of Magnesia10 in 1 CASESUSPENSION109
63739-196-10Milk of Magnesia10 in 1 TRAYSUSPENSION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-196MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [MCKESSON CORPORATION DBA SKY PACKAGING]93 package rows20250308_978d7aa4-24aa-4fac-91af-6d6f228fefaf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-196-01ML - Milliliter63739-19679a1d0dd-3ccc-45c7-ab55-c94f3477c8e212024-02-14
63739-196-10ML - Milliliter63739-196f2ff0e93-7f2d-4066-9c6f-e0584c05509812024-02-14

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63739-19663739-196-01, 63739-196-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
ac9c1e4b-477f-4cbd-a369-60d1080991cc978d7aa4-24aa-4fac-91af-6d6f228fefaf2024-10-21WarningsExact identifier
spl id: ac9c1e4b-477f-4cbd-a369-60d1080991cc
spl set id: 978d7aa4-24aa-4fac-91af-6d6f228fefaf

Reported adverse events (FAERS/openFDA)#

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