FDA.reportPublic FDA data

Magnesium Citrate

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:52:10

Label at a glance#

ProductMagnesium Citrate Lemon ReadyInCase
Active ingredientMAGNESIUM CITRATE
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours

Dosage and administration

drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses adults and children 12 years of age and over 1/2 bottle to 1 bottle (10 fl oz)  children 6 to 11 years of age  1/3 bottle to 1/2 bottle children under 6 years of age  consult a doctor 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium citrate 1.745g per fl. oz.

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

Do not use

OTC - DO NOT USE SECTION

laxative products for longer than 1 week unless directed by a doctor. 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium restricted diet
  • a sodium restricted diet
  • stomach pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that lasts more than 1 week

ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

 presently taking a prescription drug.

When using this product,

OTC - WHEN USING SECTION

do not exceed the maximum recommended daily dosage in a 24 hour period. 

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition. 

If pregnant or breast-feeding,

PREGNANCY 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 (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses
adults and children 12 years of age and over1/2 bottle to 1 bottle (10 fl oz) 
children 6 to 11 years of age 1/3 bottle to 1/2 bottle
children under 6 years of age consult a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • each fluid ounce contains: magnesium 280 mg, sodium 37 mg
  • store between 46-86ºF (8-30ºC). Do not refrigerate
  • protect from excessive heat and freezing
  • discard unused product within 24 hours of opening bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, purified water, saccharin sodium, sodium bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4757-12024-06-14C16284748780-1ba0f9c33-4db1-a910-e053-dadaa90a0b85Drug Facts
68071-4757-12023-01-30C16284748780-1ba0f9c33-4db1-a910-e053-dadaa90a0b85Drug Facts
68071-4757-12021-02-17C16284748780-1ba0f9c33-4db1-a910-e053-dadaa90a0b85Drug Facts
68071-4757-12021-01-29C16284748780-1ba0f9c33-4db1-a910-e053-dadaa90a0b85Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49580-0329-1ML - Milliliter49580-0329e0d8b030-a881-4911-9be4-fe70b2417c0112018-11-06

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
68071-475768071-4757-1
49580-0329

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
SODIUM BICARBONATE8MDF5V39QOIACT
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
1adb64de-d142-2e42-e063-6294a90a64d18150b3c3-bfc9-0ca0-e053-2a91aa0a52d72024-06-14WarningsExact identifier
spl set id: 8150b3c3-bfc9-0ca0-e053-2a91aa0a52d7

Reported adverse events (FAERS/openFDA)#

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