FDA.reportPublic FDA data

Milk of Magnesia

Manufacturer
Kesin Pharma Corporation
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:41

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections

Storage and handling

each teaspoonful (5 mL) contains: magnesium 400 mg store at 20°C to 25°C (68°F to 77°F). Avoid freezing Protect from light Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms: NDC 81033-014-30: 30 mL unit-dose cup NDC 81033-014-52: Case containing 100 unit-dose cups of 30 mL 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

INDICATIONS & USAGE SECTION

Uses

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 SECTION

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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
AgeDose
adults and children 12 years of age and over 5 mL 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
AgeDose
adults and children 12 years and older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years of age15 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 20°C to 25°C (68°F to 77°F).
  • Avoid freezing
  • Protect from light
  • Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms:

NDC 81033-014-30: 30 mL unit-dose cup

NDC 81033-014-52: Case containing 100 unit-dose cups of 30 mL each.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, fumed silica, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

PIS-014-V01

Rev. 09/2025

Kesin Pharma LogoKesin Pharma Logo

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-014-52

Milk of Magnesia, USP 2400 mg per 30 mL

Delivers 30 mL

Case = 100 UD Cups

Milk of Magnesia 30 mL Case Label 100 ctMilk of Magnesia 30 mL Case Label 100 ct

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

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
81033-014-30Milk of Magnesia30 mL in 1 CUP, UNIT-DOSESUSPENSION301
81033-014-52Milk of Magnesia100 in 1 CASESUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-014-30ML - Milliliter81033-014d8616778-365a-4d08-a850-8d28d62c0ff612025-11-13
81033-014-52ML - Milliliter81033-0143ebe1f74-0115-4a62-9727-4e7b7451429812025-11-13

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
81033-01481033-014-30, 81033-014-52

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
SILICAETJ7Z6XBU4IACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
MAGNESIUM HYDROXIDENBZ3QY004SACTIB

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
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
ndc (package): 81033-014-30
ndc (package): 81033-014-52
ndc (product): 81033-014
ndc11 (package): 81033001452
ndc11 (package): 81033001430
spl id: 3f7cff50-749c-5275-e063-6394a90af407
spl set id: 3f7cff50-749b-5275-e063-6394a90af407

Reported adverse events (FAERS/openFDA)#

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