Label: PEPSOM FLYING P EPSOM SALT- magnesium sulfate for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 26, 2010

If you are a consumer or patient please visit this version.

  • 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
  •  

    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

    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

    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.

    For information and more great tips
    Visit us at:
    www.pepsom.com

  • INGREDIENTS AND APPEARANCE
    PEPSOM FLYING P EPSOM SALT  
    magnesium sulfate for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51619-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Magnesium Sulfate, Unspecified (UNII: DE08037SAB) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Sulfate, Unspecified1 kg  in 1 kg
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51619-600-841.81 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/09/2009
    Labeler - The Pepsom Group, Inc. (012727382)
    Establishment
    NameAddressID/FEIBusiness Operations
    PACA Foods, Inc.791804123MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH, Werk Werra, Standort Wintershall506759815API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH, Werk Werra, Standort Hattorf507531213API MANUFACTURE