EPSOM SALT- magnesium sulfate crystal

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Saline Laxative Uses for Oral Laxative - for relief of occasional constipation (irregularity) - this product generally produces bowel movement in 1/2 to 6 hours taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work. you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
70000-0021-1, 70000-0021-2

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.

----------

Leader Epsom Salt

SAFETY SEAL

TAMPER EVIDENT PACKAGING:

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

for relief of occasional constipation (irregularity)

this product generally produces bowel movement in 1/2 to 6 hours

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 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 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

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

each teaspoon (5 grams) contains: magnesium 495 mg

claims

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

Directions: {For a relaxing bath/soak,} generously {or liberally} sprinkle {or pour} LEADER Epsom

Salt into warm, running bath water

Caution: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENE OF

INFECITION, 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.

Question and comments?

1-800-593-0593

Adverse reactions section

Cardinal Health

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1800-200-6313

Essential to Care since 1979

2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO,

LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

ALL LEADER Brand Product Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied

CIN 5516083 REV 4/19

principal display panel

CUT ALONG DOTTED LINE AND PRESS ZIPPER TO RESEAL

LEADER

NDC 70000-0021-1

EPSOM

SALT

Magnesium Sulfate USP, 100%

Saline Laxative

Saine Laxative

For Relief of Occasional

Constipation

Soaking Aid

For Minor Sprains

and Bruises

100% Money

Back Guarantee

Net WT 1 LB (454 g)

EPSOM SALT

magnesium sulfate crystal

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 0 21

Route of Administration

ORAL, TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8 6 9 8 T) (MAGNESIUM

CATION - UNII:T6 V3LHY8 38 )

MAGNESIUM SULFATE

HEPTAHYDRATE

1 g in 1 g

Cardinal Health

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 0 21-2

18 14 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 3/26 /20 12

2

NDC:70 0 0 0 -0 0 21-1

454 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 3/26 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 3/26 /20 12

Labeler -

Cardinal Health (097537435)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (70 0 0 0 -0 0 21)

Revised: 1/2020

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