EPSOM SALT- magnesium sulfate granule, for solution 
TOPCO Associates, LLC

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.

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Drug Facts

To Open

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TEP

Tamper Evident Packaging:

Caution: This package has been sealed for your protection. do not use if package is open, torn or multiated

Active ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

purpose

Saline laxative

Uses

Uses for Oral Laxative

For Soaking

For external use as a soaking aid for minor sprains and bruises.

Warnings

Warnings for Soaking

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.

Ask a Doctor before use if you have

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.

directions

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

Directions for Soaking

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.

Other information

Adverse reaction section

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL60007

1-888-423-0139

topcare@topco@com

principal display panel

Cut along dotted line and press zipper to reseal.

TopCare

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

M​g​SO​4 - ​7H​2​O

Saline Laxative

Soaking  Aid

NEW WT 16 OZ (1 LB) 454g

image description


EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-602
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:36800-602-01 454 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1999
2 NDC:36800-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 07/15/1999
Labeler - TOPCO Associates, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(36800-602)

Revised: 6/2016
Document Id: 004fff94-397d-4bd3-9dbc-2346a6020c73
Set id: 72f69aa0-381a-4e5c-975d-3a73fdc1b377
Version: 2
Effective Time: 20160630
 
TOPCO Associates, LLC