FDA.reportPublic FDA data

Milk of Magnesia

Manufacturer
Aurohealth LLC
Effective date
2020-11-16
Label type
Human OTC Drug Label
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:05:30

Label at a glance#

ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure9 sections

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, only use the dosing cup provided do not use any other dosing device TBSP = Tablespoon, mL = milliliter age dose adults and children 12 years and older 30 m...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide USP 1200 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Use

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ 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

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, 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 (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 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, only use the dosing cup provided
  • do not use any other dosing device
  • TBSP = Tablespoon, mL = milliliter

age
dose
adults and children 12 years and older
30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years
15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 years
ask a doctor

Other information
 

  • each tablespoon (15 mL) contains : calcium 20 mg, magnesium 500 mg, and sodium 1.43 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 28, flavor, glycerin, purified water, saccharin sodium, xanthan gum.

Questions or comments?

1-855-274-4122
* This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Phillips’® Milk of Magnesia.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-321-16
*Compare to the active ingredient
in Phillips’® Milk of Magnesia
Milk of
Magnesia
 Saline Laxative
Each 15 mL (1TBSP) dose of
oral solution contains:
1200 mg - Magnesium hydroxide USP

  • Very low sodium
  • Sugar Free
  • Stimulant Free
  • Comfortable, Cramp Free Relief

    Contains: Less than 0.5% alcohol

TAMPER-EVIDENT: Do not use
if imprinted neckband is missing or broken.

Cherry Flavor          12 FL OZ (355 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) BottlePACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-32158602-321-16, 58602-321-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
D&C RED NO. 28767IP0Y5NHIACT
CHERRYBUC5I9595WIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT

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
217528b2-354f-482b-b8fd-a014c756cbb0b9216c44-7103-44c8-81a1-8c2ea19e9cdb2020-11-16WarningsExact identifier
spl id: 217528b2-354f-482b-b8fd-a014c756cbb0
spl set id: b9216c44-7103-44c8-81a1-8c2ea19e9cdb

Reported adverse events (FAERS/openFDA)#

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