MedPath

Epsom Salt

Best Choice 602.002/602AA Epsom Salt

Approved
Approval ID

ff539c1c-9ed3-49be-9b30-1858f12e1e90

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Valu Merchandisers, Co.

DUNS: 868703513

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 Code63941-602
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Magnesium Sulfate
Product Specifications
Route of AdministrationORAL, TOPICAL
Effective DateJuly 7, 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: 7/7/2025

principal display panel

Cut along dotted line and press zipper to reseal.

Best Choice ®

Epsom Salt

Magnesium Sulfate U.S.P.

MgSO 4• 7H 2O

  • Saline Laxative For relief of Occasional Constipation
  • Soaking Aid For Minor Sprains and Bruises

NET WT 1 LB (454 g)

image description

INDICATIONS & USAGE SECTION

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

Use

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

ADVERSE REACTIONS SECTION

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

ADVERSE REACTION

Proudly Distributed By:

Valu Merchandisers, Co.

5000 Kansas Ave

Kansas City, KS 66106

Best Choice ®

100% Guaranteed

www.bestchoicebrand.com

BEST CHOICE

SPL UNCLASSIFIED SECTION

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

Claims

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

**DIRECTIONS:**Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling for 30 minutes up to three times a day. For less intensive soak, use 1 or 2 cupfuls in a bath. Use warm water for best results.

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

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredient

Magnesium sulfate USP (heptahydrate) 100%

OTC - PURPOSE SECTION

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

Purpose

Saline Laxative

WARNINGS SECTION

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

Warnings

for this product

OTC - ASK DOCTOR SECTION

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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: 7/7/2025

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

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

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

INACTIVE INGREDIENT SECTION

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

Inactive Ingredient

None

OTHER SAFETY INFORMATION

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

Other information

  • magnesium content 495 mg per teaspoon (5 grams)

OTC - QUESTIONS SECTION

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

Questions?

1-888-593-0593

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Epsom Salt - FDA Drug Approval Details