FDA.reportPublic FDA data

Epsom Salt

Manufacturer
Frog Prince(China)Daily Chemicals Co., Ltd.
Effective date
2020-04-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:07:58

Label at a glance#

ProductEpsom Salt
Active ingredientMAGNESIUM SULFATE, UNSPECIFIED FORM
Label structure13 sections

Indications and uses

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

Dosage and administration

■do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours age dose adults and children 2-4 level teaspoons dissolved 12 years and older in a full glass (8oz) of water children 6 to 1-2 level teaspoons dissolved 11 years in a full glass (8oz) of water Not recommended for children under 6 years of age

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium sulfate USP 100%

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

■ relieves occasional constipation (irregularity)

■ generally produces bowel movement in 1/2 to 6 hours

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ kidney disease ■ a magnesium restricted diet ■ stomach pain, nausea or vomiting ■ noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before using if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.

■ you need to use a laxative for more than 1 week.

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

■do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours

age dose

adults and children 2-4 level teaspoons dissolved

12 years and older in a full glass (8oz) of water

children 6 to 1-2 level teaspoons dissolved

11 years in a full glass (8oz) of water

Not recommended for children under 6 years of age

Inactive ingredients

INACTIVE INGREDIENT SECTION

NONE

Other information

OTHER SAFETY INFORMATION

■ each teaspoon contains magnesium 493 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11140 EPSOM SALT11140 EPSOM SALT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN5
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD5
1053346Epsom salt 100 % Granules for Oral SolutionSY5
1053346magnesium sulfate 100 % Granules for Oral SolutionSY5

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43221-001-042022-01-28C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-162022-01-28C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-192022-01-28C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-042020-04-25C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-162020-04-25C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-192020-04-25C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-042020-01-31C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-162020-01-31C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS
43221-001-192020-01-31C16284748780-19d75b9d0-61ba-f424-e053-dadaa90a57ceEPSOM SALTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43221-001-04Epsom Salt1810 g in 1 POUCHGRANULE18105
43221-001-16Epsom Salt454 g in 1 POUCHGRANULE4545
43221-001-19Epsom Salt544 g in 1 POUCHGRANULE5445

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43221-001EPSOM SALT (MAGNESIUM SULFATE) GRANULE [FROG PRINCE(CHINA)DAILY CHEMICALS CO., LTD.]5Legacy NDC, 3 package rows20200426_3d19523d-7cc3-2f2f-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43221-00143221-001-19, 43221-001-16, 43221-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABACTIB
MAGNESIUMI38ZP9992AIACT

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
f357f581-e4be-4909-bc15-c4d7156dfa1d3d19523d-7cc3-2f2f-e054-00144ff88e882020-04-25WarningsExact identifier
spl id: f357f581-e4be-4909-bc15-c4d7156dfa1d
spl set id: 3d19523d-7cc3-2f2f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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