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Epsom Salt by FOODHOLD U.S.A., LLC

Medically reviewed on May 15, 2018

Dosage form: granule, for solution
Ingredients: MAGNESIUM SULFATE HEPTAHYDRATE 1g in 1g
Labeler: FOODHOLD U.S.A., LLC
NDC Code: 41520-055

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.

Epsom Salt

TEP

Tamper Evident Packaging:

Caution: this package has been sealed for your protection.

Do not use if package is open, torn or mutilated

Claims

Epsom Salt

Magnesium Sulfate U.S.P.

MgSO4 - 7H2O

Active ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

External use soaking aid

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

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

Warnings

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.

Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican

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:

Dissolve 2 cups of CareOne Epsom Salt per fallon of water.  Apply with bandages or toweling for 30 minutes up to three times a day.  For less intensive soak, use 1 or 2 cups in a bath.  Use warm water for best results

Other information
  • magnesium content 495 mg per teaspoon (5 grams)

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Quality Guaranteed or your money back.

principal display panel

CAREONE

EPSOM

SALKT

MAGNESIUM SULFATE U.S.P.

  • SALINE LAXATIVE
  • SOAKING AID

For relief of occasional constipation

For minor sprains and bruises

NET WT 16 OZ

(1 LB) 454 g

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-055
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:41520-055-43454 g in 1 POUCH
2NDC:41520-055-071814 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/06/2015
Labeler - FOODHOLD U.S.A., LLC (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(41520-055)

 
FOODHOLD U.S.A., LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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