Epsom Salt Crystal
FDA Label NDC 70000-0021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Epsom Salt (NDC 70000-0021). 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 safety seal, active ingredient, purpose, uses, warnings, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Safety Seal

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS 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

Uses

Uses for Oral Laxative

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

Warnings

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

Other Information

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

Claims

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

Directions: {For a relaxing bath/soak,} generously {or liberally} sprinkle  {or pour} LEADER Epsom Salt into warm, running bath water

Caution: IF  PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENE OF INFECITION, 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.

Question And Comments?

1-800-593-0593

Adverse Reactions Section

Cardinal Health

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1800-200-6313

Essential to Care since 1979

2019 Cardinal Health.  All Rights Reserved.  CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

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Return to place of purchase if not satisfied

CIN 5516083  REV 4/19

Principal Display Panel

CUT ALONG DOTTED LINE AND PRESS ZIPPER TO RESEAL

LEADER

NDC 70000-0021-1

EPSOM

SALT

Magnesium Sulfate USP, 100%

Saline Laxative

Saine Laxative

For Relief of Occasional

Constipation

Soaking Aid

For Minor Sprains

and Bruises

100% Money

Back Guarantee

Net WT 1 LB (454 g)

Image Description (Mm1)

Image Description (Mm1)

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