Epsom Salt Granule, For Solution
FDA Label NDC 0363-0942

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Epsom Salt (NDC 0363-0942). 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 tamper evident, active ingredient, purpose, uses, warnings for soaking, ask a doctor before use, ask a doctor or pharmacist, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tamper Evident

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE AS BEEN SEALED FOR YOUR PROTECTION.  DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED.

Active Ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

Purpose

Saline laxative

soaking aid

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 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

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.

    For a less intensive soak, use 1 or 2 cupfuls in a bath.  Use warm water for best results.

Other Information

  • magnesium content 495 mg per teaspoon (5 grams)

Questions?

1-888-593-0593

Adverse Reaction Section

DISTRIBUTED BY: WALREEN CO.

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Epsom Salt

Magnesium Sulfate U.S.P.

Saline laxative for the relief of occasional constipation

Soaking aid for minor sprains & bruises

NET WT 6 LB (2.72 kg)

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