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

Cut along dotted line and press zipper to reseal

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

Active ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

purpose

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

Ask a doctor before use if you have

Ask a doctor or pharmacist

Ask a doctor or pharmacist befoe 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

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

directions

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

Other information

Adverse reaction section

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL60007

1-888-423-0139

topcare@topco@com

Principal display panel

TOPCARE

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

MGSO4 - 7H20

Saline Laxative

Soaking Aid

NET WT 16 OZ (1 LB) 454 g

image description

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-602
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE (MAGNESIUM CATION) MAGNESIUM SULFATE1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-602-43454 g in 1 POUCH
2NDC:36800-602-071814 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33407/15/1999
Labeler - TOPCO Associates, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(36800-602)

Revised: 1/2013
Document Id: d4bfad7f-3211-4068-a999-a653f1fc2900
Set id: 72f69aa0-381a-4e5c-975d-3a73fdc1b377
Version: 1
Effective Time: 20130131
 
TOPCO Associates, LLC