PEPSOM FLYING P EPSOM SALT- magnesium sulfate for solution

PEPSOM FLYING P EPSOM SALT by

Drug Labeling and Warnings

PEPSOM FLYING P EPSOM SALT by is a Otc medication manufactured, distributed, or labeled by The Pepsom Group, Inc., PACA Foods, Inc., K+S KALI GmbH, Werk Werra, Standort Wintershall, K+S KALI GmbH, Werk Werra, Standort Hattorf. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51619-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Magnesium Sulfate, Unspecified (UNII: DE08037SAB) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Sulfate, Unspecified	1 kg  in 1 kg

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51619-600-84	1.81 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/09/2009

Labeler - The Pepsom Group, Inc. (012727382)

Establishment
Name	Address	ID/FEI	Business Operations
PACA Foods, Inc.		791804123	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
K+S KALI GmbH, Werk Werra, Standort Wintershall		506759815	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
K+S KALI GmbH, Werk Werra, Standort Hattorf		507531213	API MANUFACTURE