FDA.reportPublic FDA data

Sal Inglesa

Manufacturer
Menper Distributors, Inc | DRLZ Enterprises LLC
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:11

Label at a glance#

ProductSal Inglesa EPSOM SALT
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure8 sections

Indications and uses

For relief of occasional constipation (irregularity). Generally produces bowel movement in ½ to 6 hours.

Dosage and administration

tbsp = tablespoon 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. do not exceed maximum daily dosage, unless directed by a doctor adults and children 12 years of age and older 2-4 level teaspoons dissolved in a full glass (8oz) of water children 6 to under 12 years of age 1-2 level teaspoons dissolved in a full glass (8oz) of water children ...

Label contents#

Full prescribing information#

Active Ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient Purpose
Magensium sulfate heptahydrate 100%....................................Laxative

Uses

INDICATIONS & USAGE SECTION

For relief of occasional constipation (irregularity). Generally produces bowel movement in ½ to 6 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products for more than 1 week unless directed

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 last more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You have rectal bleeding or 
  • Fail to have a bowel movement after use. This may indicate a serious condition.
  • You need to use a laxative for more than a week

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs 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

  • tbsp = tablespoon
  • 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.
  • do not exceed maximum daily dosage, unless directed by a doctor

adults and children 12 years of age and older

2-4 level teaspoons dissolved in a full glass (8oz) of water

children 6 to under 12 years of age1-2 level teaspoons dissolved in a full glass (8oz) of water

children under 6 years of age

Not recomended

Other information

OTHER SAFETY INFORMATION

  • each teaspoon (5g) contains: magnesium 495 mg
  • do not use if there is evidence of tampering.
  • store between 15-30°C (59-86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

None

Questions?

OTC - QUESTIONS SECTION

+1-800-56035223 (M-F)9 AM - 4 PM EST Eastern

Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sal inglesaSal inglesa

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN1
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD1
1053346Epsom salt 100 % Granules for Oral SolutionSY1
1053346magnesium sulfate 100 % Granules for Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130042279271019GTIN-13: 0042279271019
EAN-13: 0042279271019
GTIN-12: 042279271019
UPC-A: 042279271019
GTIN storage (14 digits): 00042279271019		53145-580.jpg

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
53145-580-01Sal InglesaEPSOM SALT80 g in 1 BOTTLECRYSTAL801

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-58053145-580-01

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
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
ndc (package): 53145-580-01
ndc (product): 53145-580
ndc11 (package): 53145058001
spl id: 8c7586c6-a601-4aad-96aa-234abbb0199e
spl set id: 247aa3a3-d38f-4799-b44d-dfe18324fd0c

Reported adverse events (FAERS/openFDA)#

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