FDA.reportPublic FDA data

Milk of Magnesia

Manufacturer
Walgreens
Effective date
2020-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:07:17

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

do not exceed the maximum recommended daily dose in a 24-hour period shake well before using mL = milliliter measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product 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 30 mL to 60 mL ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 1200 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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 use a laxative for more than 1 week

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach off children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed the maximum recommended daily dose in a 24-hour period
  • shake well before using
  • mL = milliliter
  • measure only with dosing cup provided. do not use any other dosing device.
  • keep dosing cup with product
  • 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 30 mL to 60 mL 
children 6 to 11 years 15 mL to 30 mL 
children under 6 years do not use 

Other information

SPL UNCLASSIFIED SECTION

  • each 15 mL contains: magnesium 500 mg
  • store between 20-25ºC (68-77ºF). Avoid excessive heat above 40ºC (104ºF). Avoid freezing. Close cap tightly after use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Phillips'® Milk of Magnesia active ingredient††

Milk of Magnesia

MAGNESIUM HYDROXIDE 1200 mg / SALINE LAXATIVE

SUGAR FREE

STIMULANT FREE

CRAMP FREE

  • Comfortable, dependable overnight relief

ORIGINAL FLAVOR

This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® Milk of Magnesia.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Milk of Magnesia
WALGREENS Milk of Magnesia

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0847-12ML - Milliliter0363-08471e603993-8784-49de-a734-0959dd10efa412022-06-06
0363-0847-26ML - Milliliter0363-084717fd33c0-8dda-40d4-8869-89457475c4a512022-06-06

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-08470363-0847-12, 0363-0847-26

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
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT

Source Document#

Source XML · Source PDF

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
5de4f645-454c-4fa3-b4e1-6ad6df77ec009783b45a-4b4b-4940-91c0-de9b37b3824d2020-11-13WarningsExact identifier
spl id: 5de4f645-454c-4fa3-b4e1-6ad6df77ec00
spl set id: 9783b45a-4b4b-4940-91c0-de9b37b3824d

Reported adverse events (FAERS/openFDA)#

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