EPSOM SALT SALINE LAXATIVE

Manufacturer
Compania Farmaceutica, S.A. de C.V.
Effective date
2021-04-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:45:06

Label at a glance#

ProductEPSOM SALT SALINE LAXATIVE
Active ingredientMAGNESIUM SULFATE, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

For relief of occasional constipation This product generally produces bowel movement in 1/2 to 6 hours.

Dosage and administration

Adults and children 12 years of age and over: Drink a full glass (8 ounces) of liquid with each 1 packet dose.

Label contents#

Full prescribing information#

Active ingredient (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium sulfate 12 g

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation
  • This product generally produces bowel movement in 1/2 to 6 hours.

Warnings

WARNINGS SECTION

Do not 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 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement, as these may 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

Adults and children 12 years of age and over: Drink a full glass (8 ounces) of liquid with each 1 packet dose.

Other information

SPL UNCLASSIFIED SECTION

  • Magnesium Content 1.2g
  • Store at 86˚F/30˚C or cooler

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
71230-00271230-002-12

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
c77d2e72-0d37-678e-e053-2995a90ad01599a003b6-1633-43cc-a6f9-c536b0975f2b2021-07-19WarningsExact identifier
spl set id: 99a003b6-1633-43cc-a6f9-c536b0975f2b

Reported adverse events (FAERS/openFDA)#

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