FDA.reportPublic FDA data

Topcare Milk of Magnesia

Manufacturer
Topco Associates LLC
Effective date
2022-09-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:54:17

Label at a glance#

ProductTopcare Milk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure9 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in ½ to 6 hours

Dosage and administration

• 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 • for accurate dosing, use dose cup provided • mL = milliliter adults and children 12 years and older 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under ...

Storage and handling

• each 15 mL contains: calcium 20 mg and magnesium 595 mg • does not meet USP requirements for preservative effectiveness • store at 20º-25ºC (68º-77ºF) • close cap tightly after use • avoid freezing

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL)

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 ½ 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 more than 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION 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
  • for accurate dosing, use dose cup provided
  • mL = milliliter

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

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: calcium 20 mg and magnesium 595 mg
  • does not meet USP requirements for preservative effectiveness
  • store at 20º-25ºC (68º-77ºF)
  • close cap tightly after use
  • avoid freezing

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO PHILLIPS’® ORIGINAL ACTIVE INGREDIENT

STIMULANT FREE

OUR PHARMACISTS RECOMMEND

Genuine Milk of Magnesia

SALINE LAXATIVE

MAGNESIUM HYDROXIDE, 1200 mg per 15 mL

Comfortable, Cramp Free Relief

Sugar Free

#1 Doctor Recommended Saline Laxative Active Ingredient

12 FL OZ (355 mL)

ORIGINAL FLAVOR

396-88-milk-of-magnesia-1.jpg
396-88-milk-of-magnesia-1.jpg
396-88-milk-of-magnesia-2.jpg
396-88-milk-of-magnesia-2.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-396-40ML - Milliliter36800-3968a76b8b7-23d8-42d7-aa4d-3fe841c4473812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S3
HYDROXIDE IONACTIVE MOIETY9159UV381P3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
36800-39636800-396-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
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
17e2267d-4124-4da4-94a1-f41f7c10b807ac8aa135-2dc0-499d-9f4a-8d689dc4ea6f2022-09-02WarningsExact identifier
spl id: 17e2267d-4124-4da4-94a1-f41f7c10b807
spl set id: ac8aa135-2dc0-499d-9f4a-8d689dc4ea6f

Reported adverse events (FAERS/openFDA)#

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