Epsom Salt Granule, For Solution
FDA Label NDC 76162-029

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Epsom Salt (NDC 76162-029). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ 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

→ Other

→ Principal Display Panel

Active Ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

Purpose

Saline laxative

Uses

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 content 495 mg

Other

Tamper Evident Packaging:

Caution: This package has been sealed for your protection. Do not use if package is open, torn or multiated. Cut along dotted line and press zipper to reseal.

SOAKING SOLUTION
For external use as a soaking aid for minor sprains and bruises. Discover the relaxing spa like qualities of this product in your bath.

DIRECTIONS: For a relaxing bath/soak, generously sprinkle TopCare Epsom Salt into warm, running bath water.
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.

BEAT WINTER BLUES
Simply dissolve two cups of epsom salt in a warm bath:
• for a calm and refreshing soak
• to warm and relax your muscles

A MINERAL SPRING SPA
Springtime is your fresh start to working out, often leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in and experience the relief and relaxation.

SOAK IN SUMMER SALTS
Summertime is filled with fun outdoor activities like hiking, playing sports, gardening in your backyard and more. Dissolve two cups of epsom salt in warm bath water to soothe away your muscle aches and pains that summer fun activities can bring.

RELAX INTO AUTUMN
By dissolving two cups of epsom salt in a warm bath, you'll be able to:
• revitalize tired and aching muscles
• feel refreshed and rejuvenated