FDA.reportPublic FDA data

Magnesium Citrate

Manufacturer
Cardinal Health | Consumer Product Partners, LLC
Effective date
2024-09-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:55:17

Label at a glance#

ProductMagnesium Citrate
Active ingredientMAGNESIUM CITRATE
Label structure13 sections

Indications and uses

for relief of occasiona constipation (irregularity). Generally produces bowel movement in 1/2 to 6 house

Dosage and administration

shake well before using drink a full glass (8 ounces) of liquid each dose may be taken as a single dose or in a divided doses adults and children 12 years of age and over - 6.5 - 10 fl oz maximum 10 fl oz in 24 hours childrem 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours chidlren under 2 years of age- ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient in each fl oz 

Magnesium citrate 1.745 g

Purpose

OTC - PURPOSE SECTION

Saline Laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasiona constipation (irregularity).
  • Generally produces bowel movement in 1/2 to 6 house

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium restricted diet
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other drug.
  • Take this product 2 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 failure to have a bowel movement after use.  These could be signs of a serious condition.

If pregnant

PREGNANCY SECTION

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Store at temperatures between 46° and 86°F (8° and 30°C)

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • drink a full glass (8 ounces) of liquid each dose
  • may be taken as a single dose or in a divided doses

adults and children 12 years of age and over - 6.5 - 10 fl oz maximum 10 fl oz in 24 hours

childrem 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

chidlren under 2 years of age- ask a doctor

other information

SPL UNCLASSIFIED SECTION

  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Adverse reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0575-1

Sugar-Free

Magnesium Citrate

Saline Laxative

Cherry

Flavor

Non-Pasterurzed

Break Resistant

BPA-Free

100% Money Back Guarantee

10 FL OZ (296 mL)

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0575-1ML - Milliliter70000-0575556ec53d-e214-4d44-b729-452080c21b3912022-05-04

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-057570000-0575-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
MAGNESIUM CITRATERHO26O1T9VACTIB

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
2516be66-a1e1-e276-e063-6394a90aa658b70ecfb5-3a31-4566-8faa-3eea735239582024-10-22Warnings, Adverse reactionsExact identifier
spl set id: b70ecfb5-3a31-4566-8faa-3eea73523958

Reported adverse events (FAERS/openFDA)#

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