FDA.reportPublic FDA data

SUNMARK MILK OF MAGNESIA ORIGINAL

Manufacturer
STRATEGIC SOURCING SERVICES LLC | GCP Laboratories
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:40

Label at a glance#

ProductSUNMARK MILK OF MAGNESIA ORIGINAL
Active ingredientMAGNESIUM HYDROXIDE
Label structure8 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 for accurate dosing, only use the dosing cup provided mL = milliliter adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 ...

Storage and handling

each 15 mL contains: magnesium 500 mg store at room temperature tightly closed do not freeze close cap tightly after use

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 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 presently 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 right away 1-800-222-1222.

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
  • for accurate dosing, only use the dosing cup provided
  • mL = milliliter
adults and children 12 years and over30 mL to 60 mL
children 6 to 11 years15 mL to 30 mL
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: magnesium 500 mg
  • store at room temperature tightly closed
  • do not freeze
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hypochlorite

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-540-3765
Monday to Friday 8am to 6pm EST

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0043-1ML - Milliliter70677-004383a4f1fb-eb27-4c82-8f85-3f0a2a1b5ac012021-08-05

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
70677-004370677-0043-1

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 · 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
091c2efd-593f-1123-e063-6294a90acef17d4f5d3c-879a-a181-e053-2991aa0a66232023-11-01WarningsExact identifier
spl id: 091c2efd-593f-1123-e063-6294a90acef1
spl set id: 7d4f5d3c-879a-a181-e053-2991aa0a6623

Reported adverse events (FAERS/openFDA)#

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