Epsom Salt Granule, For Solution
FDA Label NDC 72036-602

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Epsom Salt (NDC 72036-602). 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 tep statement, disclaimer, active ingredient, purpose, use, warnings, ask a doctor if you have, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tep Statement

Tamper Evident Packaging

Caution: This package has been sealed for your protection.

Do not use if package is open, torn or mulitated

Disclaimer

FOR EXTERNAL USE AS A SOAKING AID FOR MINOR SPRAINS AND BRUISES.

DIRECTIONS: For a 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.

Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Use

Uses for Laxative

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

Warnings

Before use

Ask A Doctor 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 help 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

Other Information

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

Inactive Ingredients

None

Adverse Reaction

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC. MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Principal Panel Display

Cut along dotted line and press zipper to reseal.

Harris Teeter ™

EPSOM SALT

MAGNESIUM SULFATE U.S.P.

SALINE LAXATIVE

For Relief of Occasional Constipation

SOAKING AID

For Minor Sprains and Bruises

NET WT. 4 LB (1.81 kg)

EPSOM SALT

Magnesium Sulfate U.S.P.

NET WT. 4 LB (1.81 kg)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.