EPSOM SALT- magnesium sulfate crystal 
Cardinal Health

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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Leader Epsom Salt

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

Active ingredient

Magnesium sulfate USP (heptahydrate)100%

Purpose

Saline Laxative

Uses

Uses for Oral Laxative

Warnings

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

Other information

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 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 warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Principal Display Panel

Cut along dotted line and press zipper to reseal.

NDC 37205-602-07

LEADER Epsom Salt

Magnesium Sulfate U.S.P.

M​g​SO​4 ​ 7H​2​0

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

NET WT 4 LB (1.81 kg)

image description

602.002/602AA

EPSOM SALT 
magnesium sulfate crystal
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-602
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-602-071814 g in 1 POUCH; Type 0: Not a Combination Product03/26/2012
2NDC:37205-602-43454 g in 1 POUCH; Type 0: Not a Combination Product03/26/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/26/2012
Labeler - Cardinal Health (097537435)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(37205-602)

Revised: 8/2017
Document Id: d9db2e8d-4b50-49a5-a5c2-050646250511
Set id: 88cad63f-8eb0-41b8-8d33-6b285a606c65
Version: 5
Effective Time: 20170811
 
Cardinal Health