FDA.reportPublic FDA data

Milk of Magnesia Concentrate

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:36:47

Label at a glance#

ProductMilk of Magnesia Concentrate
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections

Indications and uses

heartburn upset/sour stomach acid indigestion relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.

Dosage and administration

do not exceed the maximum recommended daily dose of 20 mL 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 mL (1 teaspoonful) children under 12 years of age ask a doctor do not exceed the maximum recommended daily dose in a 24 hour period shake well before use dose may be taken once a day preferably at bedtime, in divided doses, or as ...

Storage and handling

each teaspoonful (5 mL) contains: magnesium 1000 mg Sodium Content: 19 mg/10 mL store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing. Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form: NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 2400 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

SPL UNCLASSIFIED SECTION

  • relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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 of 20 mL 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 mL (1 teaspoonful)
children under 12 years of ageask a doctor

As a Laxative

SPL UNCLASSIFIED SECTION

  • do not exceed the maximum recommended daily dose 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
adults and children 12 years and older15 mL to 30 mL
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each teaspoonful (5 mL) contains: magnesium 1000 mg
  • Sodium Content: 19 mg/10 mL
  • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
  • Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
dihydrate, sodium saccharin, sorbitol, and sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R07/21

PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0940-10

Milk of Magnesia Concentrate

Each 10 mL contains:

Magnesium Hydroxide 2400 mg.

ANTACID/ SALINE LAXATIVE

SHAKE WELL

Package Not Child-Resistant

See Insert

PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314087magnesium hydroxide 2400 MG in 10 mL Oral SuspensionPSN4
314087magnesium hydroxide 240 MG/ML Oral SuspensionSCD4
314087magnesium hydroxide 1200 MG per 5 ML Oral SuspensionSY4
314087magnesium hydroxide 2400 MG per 10 ML Oral SuspensionSY4
314087milk of magnesia 240 MG/ML Oral SuspensionSY4

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
0121-0940-00Milk of Magnesia Concentrate10 in 1 TRAYSUSPENSION104
0121-0940-00Milk of Magnesia Concentrate10 in 1 CASESUSPENSION104
0121-0940-10Milk of Magnesia Concentrate10 mL in 1 CUP, UNIT-DOSESUSPENSION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0940MILK OF MAGNESIA CONCENTRATE (MAGNESIUM HYDROXIDE) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]4Current NDC, Legacy NDC, 3 package rows20241114_2a99a1a8-a830-429f-9cfd-3f29c3d3547c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0940-00ML - Milliliter0121-0940bec3c0a2-6658-4e1e-a155-5d23bc7b719412022-02-07
0121-0940-10ML - Milliliter0121-0940f72ed05d-41e1-4922-8ed4-2c30c75f421212022-02-07

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-09400121-0940-10, 0121-0940-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL SOLUTION8KW3E207O2IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
ndc (package): 0121-0940-00
ndc (package): 0121-0940-10
ndc (product): 0121-0940
ndc11 (package): 00121094010
ndc11 (package): 00121094000
spl id: ea20258e-bda5-46b8-8c87-1eb9e30adbc4
spl set id: 2a99a1a8-a830-429f-9cfd-3f29c3d3547c

Reported adverse events (FAERS/openFDA)#

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