Epsom Salt Granule, For Solution
FDA Label NDC 55910-038

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Epsom Salt (NDC 55910-038). 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, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if, 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

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Use

  • for relief of occasional constipation (irregularity)
  • for 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

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

  • magnesium content 495 mg per teaspoon (5 grams)

Other

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

DIRECTIONS: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling 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 phyusician. 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.

Since 1903

Rexall

Visit us at Rexall.com or call 1-866-4-REXALL

PACKAGED FOR DOLGENCORP,LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

Principal Display Panel

Cut along dotted line and press zipper to reseal

Kroger

From our family to yours

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 16 OZ (1 LB) 453 g

Image Description (Mm1)

Image Description (Mm1)

602.002/602AA

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