Pepsom Flying P Epsom Salt
FDA Label NDC 51619-600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Pepsom Group, Inc. for the product Pepsom Flying P Epsom Salt (NDC 51619-600). 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 active ingredient, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor:, when using this product, keep out of reach of children -, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Magnesium Sulfate U.S.P. 100% (Epsom salt)

Purpose

External...................Soaking Solution
Internal.......................Saline Laxative

Uses

External-
Soaking Solution.............Relieves muscle strains and soreness
Internal-
Saline Laxative........................Relieves occasional constipation

Warnings

Laxative

  • For occasional use only. Serious side effects from prolonged use or overdosage may occur. Do not take this product except under the advice and supervision of physician if you 
    • have kidney disease
    • are taking medications
      • Do not give to children under 6 years of age except under the advice and supervision of a physician.

Ask A Doctor Before Use If You Have

Soaking Solution

  • redness or swelling present
  • evidence of an infection
  • diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of physician

    • Laxative

    • kidney disease
    • stomach pain
    • nausea
    • a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor:

Laxative

  • if you have no bowel movement within 6 hours or rectal bleeding. These could be signs of a serious condition
    • you need a laxative for more than one week

When Using This Product

  • avoid contact with eyes or mucus membranes

Keep Out Of Reach Of Children -

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

Directions

Soaking Solution:

Bath - Dissolve 2 cups into a tub of hot water and soak for 15-30 minutes
Foot or Wrist Soak - Dissolve 2 cups into a foot bath half-full of water, soaking the injured area for 20-30 minutes. Repeat 2-3 times per day until relief is obtained

Laxative:

Children 6-12 years.........................Dissolve 1-2 level teaspoons
(5mg-10mg) into a full cup of water (8oz)
Adults and Children over 12.........Dissolve 2-4 level teaspoons
(10mg-20mg) into a full cup of water (8oz)

Inactive Ingredients

None

Questions? Comments?

1-877-FEEL-PEP

Principal Display Panel

Package Label (Flying P Epsom Salt Sm)

Package Label (Flying P Epsom Salt Sm)

RESEALABLE POUCH CUT ALONG DOTTED LINE

Epsom Salt

MAGNESIUM SULFATE U.S.P.

Soaking Aid

  • for minor sprains and bruises

    • Saline Laxative

    • for relief of occasional constipation

      • NET WT 4 LB (1.81 kg)

      RESEALABLE POUCH CUT ALONG DOTTED LINE

      EPSOM SALT IS 100% NATURAL MINERAL (Magnesium Sulfate U.S.P.).
      ENJOY THE MANY DELIGHTFUL USES AND BENEFITS OF THIS
      PURE EPSOM SALT PRODUCT.

      EPSOM SALT

      FOR EVERY SEASON

      WINTER BLUES? ADD 2 CUPS TO A WARM/HOT BATH SOAK 15-30 MIN FOR RELIEF OF ACHES AND PAINS

      SPRING BREAK? ADD A CUP INTO WASHCLOTH AND SCRUB OVER BODY TO EXFOLIATE SKIN - RINSE

      SUMMER BUMMER? FOR CONCENTRATED RELIEF FROM STINGS OR PAIN, ADD 1/2 CUP TO 1 QT. OF WATER - MAKE A DRESSING AND WRAP INJURED AREA 2-3 X A DAY

      FALL SHORT? FOR FOOT PAIN, ADD 1-2 CUPS INTO FOOTBATH OF VERY WARM WATER - SOAK 20-30 MIN

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

      DIRECTIONS:
      Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling for 30 minutes up to 3 times a day, or use as a soak or in bath. Use warm water for best results.

      CAUTION:
      If prompt relief is not obtained or if there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individual with diabetes except on the advice of a physician.

      KEEP OUT OF REACH OF CHILDREN

      100% Satisfaction-Guaranteed or your money back.

      Distributed by:
      The Pepsom Group, Inc. Miami, FL 33137
      © The Pepsom Group, Inc.

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      Visit us at:
      www.pepsom.com

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