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  5. Label Information: Epsom Salt

FDA Label for Epsom Salt

View Indications, Usage & Precautions

Table of Contents

    1. TO OPEN
    2. TEP
    3. ACTIVE INGREDIENT
    4. PURPOSE
    5. USES
    6. WARNINGS
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. ADVERSE REACTION SECTION
    15. PRINCIPAL DISPLAY PANEL

Epsom Salt Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates, Llc. 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.

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 relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours

    • 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



  • 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

    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



  • magnesium content 495 mg per teaspoon (5 grams)

Adverse Reaction Section



DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco@com

602.002/602AA


Principal Display Panel



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TopCare

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

M​g​SO​4 - ​7H​2​O

Saline Laxative

  • For Relief of Occasional Constipation

    • Soaking  Aid

    • For Minor Sprains and Bruises

      • NEW WT 16 OZ (1 LB) 454g


* Please review the disclaimer below.