FDA.reportPublic FDA data

Epsom Salts

Manufacturer
NEW PRIDE CORP | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:06

Label at a glance#

ProductEpsom Salts
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Magnesium Sulfate (heptahydrate) 100% Saline Laxative

OTC - PURPOSE SECTION

Uses

  • For relief of Occasional Constipation (Irregularity)
  • This product generally produces bowel movement

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.

INDICATIONS & USAGE SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.

WARNINGS SECTION

Warnings

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 of longer than 1 week

If pregnant or breast-feeding ask a health profesional before use

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not exceed more than 2 doses per day
  • drink a full glass (8 ounces) of liquid with each dose
  • dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.
  • adults and children 12 years and over: 2 to 4 level teaspoons (10 to 20 grams) daily
  • children 6 to under 12 years: 1 to 2 level teaspoons (5 to 10 grams) daily
  • children under 6 years: consult a doctor

INACTIVE INGREDIENT SECTION

There are no inactive ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Assured

Multipurpose

Epsom Salts

Net Wt. 16 oz (454 g)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN3
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD3
1053346Epsom salt 100 % Granules for Oral SolutionSY3
1053346magnesium sulfate 100 % Granules for Oral SolutionSY3

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
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
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
58037-008-01Epsom Salts454 g in 1 POUCHGRANULE4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58037-008EPSOM SALTS (MAGNESIUM SULFATE) GRANULE [NEW PRIDE CORP]3Current NDC, 1 package rows20241222_f6626023-4857-518b-e053-2a95a90a9821.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58037-00858037-008-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB

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
Epsom SaltsMAGNESIUM SULFATENEW PRIDE CORPf6626023-4857-518b-e053-2a95a90a98212024-12-19WarningsExact identifier
ndc (package): 58037-008-01
ndc (product): 58037-008
ndc11 (package): 58037000801
spl id: 299acaea-3ece-c645-e063-6294a90a8401
spl set id: f6626023-4857-518b-e053-2a95a90a9821

Reported adverse events (FAERS/openFDA)#

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