Epsom Salt Granule, For Solution
FDA Label NDC 36800-602

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Epsom Salt (NDC 36800-602). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding to open, tep, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

To Open

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Tep

Tamper Evident Packaging:

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

Active Ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

Purpose

Saline laxative

Uses

Uses for Oral Laxative

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

    • For Soaking

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

Warnings

Warnings for Soaking

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 physician. Keep out of reach of children.

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.

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.

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.

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children

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

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

    Directions for Soaking

    Directions: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or towelling for 30 minutes up to three times a day, or use as a soak or in bath. Use warm water for best results.

Other Information

  • magnesium content 495 mg per teaspoon (5 grams)

Adverse Reaction Section

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco@com

602.002/602AA

Principal Display Panel

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TopCare

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

M​g​SO​4 - ​7H​2​O

Saline Laxative

  • For Relief of Occasional Constipation

    • Soaking  Aid

    • For Minor Sprains and Bruises

      • NEW WT 16 OZ (1 LB) 454g

* Please review the disclaimer below.