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

16 label sections · Submitted to the FDA by Harris Teeter · 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, 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

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 relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water.

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.

Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Uses

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

Warnings

for this product

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 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.