FDA.reportPublic FDA data

Magnesium Citrate

Manufacturer
AARNA USA INC.
Effective date
2025-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:29

Label at a glance#

ProductMagnesium Citrate Saline Laxative
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 (30ml (approx. 1 Fl. oz))

OTC - ACTIVE INGREDIENT SECTION

Magnesium citrate 1.745g

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,

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 (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 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

Other information

SPL UNCLASSIFIED SECTION

  • each fliud ounce contains: magnesium 280 mg, Sodium 6.7 mg
  • store between 46º-86ºF (8º-30ºC). Do not refrigerate.
  • protect from excessive heat and freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, citric acid anhydrous, disodium edetate, lemon flavor, purified water, sorbic acid, sucralose 

Questions or comments?

OTC - QUESTIONS SECTION

Call  toll-free 1-877-225-6999.

Manufactured for:

AARNA USA Inc.

Leland , NC-28451 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

296mL296mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052760magnesium citrate 1.745 GM in 1 FL OZ Oral SolutionPSN1
1052760magnesium citrate 58.2 MG/ML Oral SolutionSCD1
1052760magnesium citrate 1.745 GM per 1 FL OZ Oral SolutionSY1
1052760magnesium citrate 1.745 GM per 29.6 ML Oral SolutionSY1
1052760magnesium citrate 1.745 GM per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0051-1Magnesium CitrateSaline Laxative296 mL in 1 BOTTLELIQUID2961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0051MAGNESIUM CITRATE SALINE LAXATIVE (MAGNESIUM CITRATE) LIQUID [AARNA USA INC.]1Current NDC, 1 package rows20250303_e7550220-df26-4a7a-a254-bebb225d9e5e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0051-1ML - Milliliter82568-005176a2ac69-162c-4904-93e1-90877d1a8eff12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-005182568-0051-1

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 CITRATERHO26O1T9VACTIB
BENZOIC ACID8SKN0B0MIMIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SORBIC ACIDX045WJ989BIACT
SUCRALOSE96K6UQ3ZD4IACT

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
Magnesium Citrate Saline LaxativeMAGNESIUM CITRATEAARNA USA INC.e7550220-df26-4a7a-a254-bebb225d9e5e2025-03-01WarningsExact identifier
ndc (package): 82568-0051-1
ndc (product): 82568-0051
ndc11 (package): 82568005101
spl id: 3c0b2226-1838-4383-8ab0-250fb8937639
spl set id: e7550220-df26-4a7a-a254-bebb225d9e5e

Reported adverse events (FAERS/openFDA)#

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