EPSOM SALT- magnesium sulfate granule, for solution

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Uses

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

WARNINGS

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.  (1-800-222-1222) immediately.

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

• magnesium content 495 mg per teaspoon (5 grams)

SPL UNCLASSIFIED SECTION

Tamper Evident Packaging:
Caution: this package has been sealed for your protection. Do not use if package is open, torn or mulitated.

Epsom Salt is a trusted remedy that is useful every season of the year
BEAT WINTER BLUES - Simply dissolve two cups of epsom salt in a warm bath to: -reduce stifness and soreness in joints - warmand comfort your muscle aches
A MINERAL SPRING SPA - Springtime is your fresh start to working out ofter leadng to overexertion. Just dissolve two cups of epsom salt in warm bat water, settle in, and experience the relief and relaxation.
FIRST AID SUMMER SALT - Dissolve two cups of epsom salt per gallon of water to make a compress. Apply as wet dressing with towel to:
relieve stiffness and sorness.
warm and comfort yor muscles aches
RELAX INTO AUTUMN - By dissolving two cups of epsom salt in a gallon of warm water, you'll be able to:
soak away tiredness and soreness
help soothe away stress

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

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

For external use as a soaking aid for minor sprains and bruises
Discover the Relaxing Spa-Like Qualities of This Product in Your Bath

Distributed by: Vi: Jon

8515 Page Avenue

St. Louis, MO 63114

V#425040  Item# 602

Principal Display Panel

SOUND BODY

Epsom Salt

Magnesium Sulfate U.S.P.

MgSO4 - 7H20

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

Discover the Relaxing Spa-Like Qualities of This Product in Your Bath

NET WT 4 LB (1.81 kg)

602.002/602AA

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-602
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-602-01	1814 g in 1 POUCH; Type 0: Not a Combination Product	07/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/21/2015

Labeler - Meijer Distribution, Inc (017885351)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50594-602)