FDA Label for Epsom Salt

View Indications, Usage & Precautions

SAFETY SEAL
ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
CLAIMS
QUESTION AND COMMENTS?
ADVERSE REACTIONS SECTION
PRINCIPAL DISPLAY PANEL

Epsom Salt Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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)

image description - mm1

* Please review the disclaimer below.

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