Epsom Salt Granule, For Solution
FDA Label NDC 83324-175

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Epsom Salt (NDC 83324-175). 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 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

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 pail, 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

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 liquie 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

  • magnesium content 495 mg per teaspoon (5 grams)

Inactive Ingredient

None

Other

Tamper Evident Packaging:
Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated

Drug Mart
EPSOM SALT
MAGNESIUM SULFATE U.S.P.
MgSO4 - 7H2O

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

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.

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.

Adverse Reaction

Distributed By:C.D.M.A., Inc

43157 W 9 mile Rd

Novi, MI 48375

www. qualitychoice.com

Questions: 800-935-2362

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Epsom

Salt

Magnesium Sulfate U.S.P.

MgSO4 - 7H2O

Saline Laxative

For Relief of Occasional

Constipation

Soaking Aid

For Minor Sprains and Bruises

NET WT 1 LB (454 g)

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