FDA.reportPublic FDA data

MILK OF MAGNESIA

Manufacturer
REMEDYREPACK INC.
Effective date
2022-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:03:59

Label at a glance#

ProductMILK OF MAGNESIA
Active ingredientMAGNESIUM HYDROXIDE
Label structure9 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 age dose adults and children 12 years and over 2 to 4 tablespoonfuls children 6 to 11 years 1 to 2 tablespoonfuls children under 6 years ask a doctor

Storage and handling

• each 15 mL tablespoonful contains: magnesium 500 mg • avoid freezing • store at room temperature tightly closed

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

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 (1-800-222-1222) 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

agedose
adults and children 12 years and over2 to 4 tablespoonfuls
children 6 to 11 years1 to 2 tablespoonfuls
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

• each 15 mL tablespoonful contains: magnesium 500 mg

• avoid freezing

• store at room temperature tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: MILK OF MAGNESIA

GENERIC: magnesium hydroxide

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-3406-0

NDC: 70518-3406-1

PACKAGING: 30 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

  • MAGNESIUM HYDROXIDE 1200mg in 15mL

INACTIVE INGREDIENT(S):

  • WATER
  • SODIUM HYPOCHLORITE

Remedy_LabelRemedy_Label

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0061-1ML - Milliliter70000-00611f4aec99-ba1d-4395-bf67-fcc5721ed49912021-12-08

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
70518-340670518-3406-1, 70518-3406-0
70000-0061

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
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDECARDINAL HEALTHaf5ddf5d-b1f5-2918-e053-2995a90a2d612023-11-07WarningsExact identifier
ndc (product): 70000-0061
fb44e956-e4fb-501a-e053-6294a90a5d70e35f148b-4ba9-4f87-9b63-ae6a65594f792023-05-09WarningsExact identifier
spl set id: e35f148b-4ba9-4f87-9b63-ae6a65594f79

Reported adverse events (FAERS/openFDA)#

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