FDA.reportPublic FDA data

ROYAL Epsom Salt

Manufacturer
Filo America | Hefei Yatai Daily-Use Chemical Industry Co., Ltd
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:35:47

Label at a glance#

ProductROYAL Epsom Salt
Active ingredientMAGNESIUM SULFATE, UNSPECIFIED FORM
Label structure16 sections

Indications and uses

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

Dosage and administration

Directions Adults and children 12 years and over - Oral dosage is 10 to 30 grams children 6 to under 12 years of age - Oral dosage is 5 to 10 grams children 2 to under 6 years of age - Oral dosage is 2.5 to 5 grams children under 2 years of age - consult a doctor Drink a full glass (8 ounces) of liquid with each dose. The dose may be taken as a single daily dose or in divided doses. 1 teaspoon equals 5 grams.

Label contents#

Full prescribing information#

OTHER SAFETY INFORMATION

Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium Sulfate

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Do no use

OTC - DO NOT USE SECTION

  • if you have kidney disease unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more 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
  • noticed a sudden change in bowel habits that persists over a period of 2 week

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Take this product two or more hours before or after other drugs.

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 help 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

Directions

Adults and children 12 years and over - Oral dosage is 10 to 30 grams

children 6 to under 12 years of age - Oral dosage is 5 to 10 grams

children 2 to under 6 years of age - Oral dosage is 2.5 to 5 grams

children under 2 years of age - consult a doctor

  • Drink a full glass (8 ounces) of liquid with each dose.
  • The dose may be taken as a single daily dose or in divided doses.
  • 1 teaspoon equals 5 grams.

Other information

OTHER SAFETY INFORMATION

  • Magnesium content 495 mg per teaspoon (5 grams)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

Questions

OTC - QUESTIONS SECTION

Questions or comments? 1-800-632-6900

Side panel information

SPL UNCLASSIFIED SECTION

Store in cool, dry place out of direct

sunlight. Package sold by weight not

volume, some settling of contents may

occur during shipment. If caking occurs,

tap pouch gently to free granules.

ROYAL

Distributed by:

Filo America Inc.

Vernon, CA 90058

United States

Made in China

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal

Epsom Salt

Magnesium Sulfate

Saline Laxative

Plain

NET WT. 4 lbs (1.8 kg)

Distributed by:

Filo America Inc.

Vernon, CA 90058

United States

Made in China

NET WT. 4 lbs (1.8 kg)

FrontFrontBackBack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN6
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD6
1053346Epsom salt 100 % Granules for Oral SolutionSY6
1053346magnesium sulfate 100 % Granules for Oral SolutionSY6

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
50438-001-00ROYAL Epsom Salt1.8 kg in 1 BAGGRANULE, FOR SOLUTION1.86

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM SULFATEACTIVE INGREDIENTDE08037SAB2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8382

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
50438-00150438-001-00

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, UNSPECIFIED FORMDE08037SABACTIB

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
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
ndc (package): 50438-001-00
ndc (product): 50438-001
ndc11 (package): 50438000100
spl id: 48fdd749-9d9f-c41a-e063-6394a90a7158
spl set id: 40eb04d2-fcc9-4ee2-8483-99699ea7e386

Reported adverse events (FAERS/openFDA)#

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