Epsom Salt
FDA Label NDC 41520-055

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foodhold U.s.a., Llc for the product Epsom Salt (NDC 41520-055). 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 tep, claims, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    Image Description (Mm1)

    Image Description (Mm1)

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