FDA.reportPublic FDA data

Epsom Salt

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 01:44:18

Label at a glance#

ProductEpsom Salt
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure17 sections

Indications and uses

for relief of occasional constipation (irregularity) this product generally produces bowel movement in 1/2 to 6 hours

Dosage and administration

do not exceed recommended daily dosage drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses 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 6 level teaspoons (10 to 30 grams) daily children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily children under 6 ye...

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED.

TopCare

health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium sulfate USP ( Heptahydrate) 100%

purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

for this product

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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 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 right away.

directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended daily dosage
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses
  • 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 6 level teaspoons (10 to 30 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 ingredients

INACTIVE INGREDIENT SECTION

None

Other information

OTHER SAFETY INFORMATION

  • each teaspoon (5 grams) contains: magnesium 495 mg 

Questions?

OTC - QUESTIONS SECTION

1-888-423-0139

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO 

Questions? 1-888-423-0139

topcare@topco@com

www.topbrand.com

QUALITY GUARANTEED

Side Panel Claims

SPL UNCLASSIFIED SECTION

TopCare ®

health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

For Use as a Laxative

Directions:Do not exceed recommended daily dosage. See Drug Facts and Directions for dosage information. Drink full glass (8 ounces) of liquid with each dose. May be taken as a single dose or in divided doses. Dissolve the dose in 8 ounces of water. Lemon juice may be added to improve taste.

Soaking Aid Directions

Directions:For a relaxing bath/soak, generously sprinkle TopCare Epsom Salt into warm, running bath water.

Foot Soak Directions:For use as a soaking solution: Dissolve this product in a small basin of water. Soak feet for 15-20 minutes.

BEAT WINTER BLUES

Simply dissolve two cups of epsom salt in a warm bath:

  • for a calm and refreshing soak
  • to warm and relax your muscles

A MINERAL SPRING SPA

Springtime is your fresh start to working out, often leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in and experience the relief and relaxation.

SOAK IN SUMMER

Summertime is filles with fun outdoor activities like hiking, playing sports, gardening in your backyard and more. Dissolve two cups of epsom salt in warm bath water to help soothe away your muscle aches and pains that summer fun activities can bring.

RELAX INTO AUTUMN

By dissolving two cups of epsom salt in a warm bath, you'll be able to:

  • revitalize tired and aching muscles
  • feel refreshed and rejuvenated

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cut along dotted line and press zipper to reseal.

Resealable Pouch

TopCare health™

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

  • Saline Laxative for Relief of Occasional Constipation
  • Soaking Aid for Minor Sprains and Bruises

NEW WT 64 OZ (4 LB) 1.81 kg

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN18
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD18
1053346Epsom salt 100 % Granules for Oral SolutionSY18
1053346magnesium sulfate 100 % Granules for Oral SolutionSY18

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
36800-602-012020-05-21C16284748780-19d75b9d0-c3ac-f424-e053-dadaa90a57ceTop Care 602.02/602AA Epsom Salt
36800-602-072020-05-21C16284748780-19d75b9d0-c3ac-f424-e053-dadaa90a57ceTop Care 602.02/602AA Epsom Salt
36800-602-012020-01-31C16284748780-19d75b9d0-c3ac-f424-e053-dadaa90a57ceTop Care 602.02/602AA Epsom Salt
36800-602-072020-01-31C16284748780-19d75b9d0-c3ac-f424-e053-dadaa90a57ceTop Care 602.02/602AA Epsom Salt

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-602-07Epsom Salt1814 g in 1 POUCHGRANULE, FOR SOLUTION181418
36800-602-43Epsom Salt454 g in 1 POUCHGRANULE, FOR SOLUTION45418
36800-602-80Epsom Salt3628 g in 1 POUCHGRANULE, FOR SOLUTION362818

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM SULFATEACTIVE INGREDIENTDE08037SAB1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381

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
36800-60236800-602-43, 36800-602-07, 36800-602-80

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 · Source PDF

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 SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-602-07
ndc (package): 36800-602-80
ndc (package): 36800-602-43
ndc (product): 36800-602
ndc11 (package): 36800060280
ndc11 (package): 36800060243
ndc11 (package): 36800060207
spl id: 4ab99ba6-4ad5-76c2-e063-6394a90ab4be
spl set id: 72f69aa0-381a-4e5c-975d-3a73fdc1b377

Reported adverse events (FAERS/openFDA)#

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