Royal Epsom Salt Granule, For Solution
FDA Label NDC 50438-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Royal Epsom Salt (NDC 50438-001). 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, do no use, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Magnesium Sulfate

Purpose

Laxative

Uses

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

Warnings

Do No Use

  • if you have kidney disease unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • kidney disease
  • a magnesium-restricted diet
  • noticed a sudden change in bowel habits that persists over a period of 2 week

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Take this product two or more hours before or after other drugs.

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 help 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

  • Drink a full glass (8 ounces) of liquid with each dose.
  • The dose may be taken as a single daily dose or in divided doses.
  • 1 teaspoon equals 5 grams.

    • Adults and children 12 years and over - Oral dosage is 10 to 30 grams

    children 6 to under 12 years of age - Oral dosage is 5 to 10 grams

    children 2 to under 6 years of age - Oral dosage is 2.5 to 5 grams

    children under 2 years of age - consult a doctor

Other Information

  • Magnesium content 495 mg per teaspoon (5 grams)

Inactive Ingredients

none

Questions

Questions or comments? 1-800-632-6900

Side Panel Information

Store in cool, dry place out of direct

sunlight. Package sold by weight not

volume, some settling of contents may

occur during shipment. If caking occurs,

tap pouch gently to free granules.

ROYAL

Distributed by:

Filo America Inc.

Vernon, CA 90058

United States

Made in China

Principal Display Panel

Royal

Epsom Salt

Magnesium Sulfate

Saline Laxative

Plain

NET WT. 4 lbs (1.8 kg)

Distributed by:

Filo America Inc.

Vernon, CA 90058

United States

Made in China

NET WT. 4 lbs (1.8 kg)

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