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 DZA Brands, LLC, 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 perists over a period of 2 weeks
• already used a laxatibe 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 durgs.  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 coud 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 - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years of age - consult a doctor

Other information

• magnesium content 495 mg per teaspoon (5 grams)

SPL UNCLASSIFIED SECTION

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

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 three tmes a day, or use as a soak or in bath. Use warm water for best results

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 04074

For product questions or concerns contact us at 1-866-322-2439

Please include UPC code and code from the package

SPL UNCLASSIFIED SECTION

Healthy Accents

Magnesium sulfate USP

Epsom Salt

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 towelling for 30 minutes up to three times a day or use in a soak or in 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 warm soaks should not be used by indifiduals with diabetes except on the advice of a physician. Keep out of reach of children.

principal display panel

healthy accents

magnesium sulfate USP

epsom salt

saline laxative for relief of occasional constipation

soaking aid for minor sprains and bruises

NET WT 1 LB (454 g) 16 OZ

602.002/602AA

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-602
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: 55316-602-07	1814 g in 1 POUCH; Type 0: Not a Combination Product	02/27/2008
2	NDC: 55316-602-06	454 g in 1 POUCH; Type 0: Not a Combination Product	02/27/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/27/2008

Labeler - DZA Brands, LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55316-602)