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 Winco Foods, LLC, Vi-Jon. 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 pail, 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

 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.

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)

Questions

Or to report and adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

SPL UNCLASSIFIED SECTION

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

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 as 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 individuals with diabetes except on the advice of a physician. Keep out of reach of children.

WinCo Foods
Epsom Salt
MAGNESIUM SULFATE U.S.P.

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

Comments & Questions?

800-824-1706 www.wincofoods.com

Principal Display Panel

ZIPPER PLACEMENT

WinCo FOODS

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgSO4 - 7H20

Saline Laxative For Relief of Occasional Constipation

Soaking Aid for Minor Sprains & Bruises

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: 67091-169
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: 67091-169-04	1814 g in 1 POUCH; Type 0: Not a Combination Product	05/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/21/2015

Labeler - Winco Foods, LLC (056098817)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(67091-169)