EPSOM SALT- magnesium sulfate granule, for solution

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by TOPCO Associates, LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

inactive ingredients

None

Other information

• each teaspoon (5 grams) contains: magnesium content 495 mg

SPL UNCLASSIFIED SECTION

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

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco@com

www.topcarebrand.com

principal display panel

TopCare health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

M gSO 47H 2O

• Saline Laxative for Relief of Occasional Constipation
• Soaking Aid for Minor Sprains and Bruises
• Plant Food Supplement for bigger, More Vigorous Plants

NEW WT 8 LB (3.63 kg)

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-029
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-029-80	3630 g in 1 POUCH; Type 0: Not a Combination Product	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	12/01/2021

Labeler - TOPCO Associates, LLC (006935977)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(76162-029)