MedPath

Epsom Salt

Meijer 602.002/602AA Epsom Salt

Approved
Approval ID

2070a4a6-7968-49f2-84ec-53bd1cd82445

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Meijer Distribution, Inc

DUNS: 006959555

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Magnesium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-602
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Magnesium Sulfate
Product Specifications
Route of AdministrationORAL, TOPICAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (1)

MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 1 g in 1 g
Code: SK47B8698T
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/30/2025

principal panel display

Cut along dotted line and press zipper to reseal.

Resealable Pouch

TAMPER EVIDENT PACKAGING:

Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated.

NDC 41250-602-07

meijer ®

Epsom Salt

Magnesium Sulfate U.S.P.

Saline Laxative

Soaking Aid

FRAGRANCE FREE

For Relief of Occasional Constipation

For minor Sprains and Bruises

Naturally derived

NET WT 4 LB (1.81 kg)

Epsom Salt

Magnesium Sulfate U.S.P.

NET WT 4 LB (1.81 kg)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/30/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/30/2025

Adverse reaction

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

The Meijer Family

www.meijer.com/satisfaction

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2025

Active ingredient

Magnesium sulfate USP (heptahydrate) 100%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/30/2025

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/30/2025

Other information

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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 7/30/2025

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/30/2025

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/30/2025

inactive ingredient

none

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/30/2025

Questions

1-888-593-0593

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/30/2025

Directions

  • 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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/30/2025

Purpose

Saline Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 7/30/2025

Warnings

for this product

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/30/2025

Ask a doctor before use if you have

  • 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/30/2025

Side panels

For external use as a soaking aid for minor sprains and bruises.

Soaking Aid Directions: For a relaxing bath/soak, generously sprinkle Meijer® Epsom Salt into warm, running bath water.

Foot Soak Directions: Dissolve this product in a small basin of water. Soak for 15-20 minutes.

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican.

Keep out of children.

Meijer ®Epsom Salt is useful every season of the year.

BEAT WINTER BLUES
Simply dissolve two cups of Meijer ®Epsom Salt in a warm bath to provide soothing relief from stress stiffness.

A MINERAL SPRING SPA
Spring is your fresh start to working out and physical activity, often leading to overexertion. Just dissolve two cups of Meijer ®Epsom Salt into warm bath water, settle in, and experience the relief and relaxation.

FIRST AID SUMMER SALT
By dissolving two cups of Meijer ®Epsom Salt in a warm bath you'll be able to:

  • revitalize tired and aching muscles
  • feel refreshed and rejuvenated

RELAX INTO AUTUMN
Dissolve two cups of Meijer ®Epsom Salt into a gallon of war water. This will soak away tiredness, soreness and help soothe away stress.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/30/2025

If pregnant or breast-feeding,

ask a health professional before use.

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Epsom Salt - FDA Drug Approval Details