FDA Label for Royal Epsom Salt

View Indications, Usage & Precautions

Royal Epsom Salt Product Label

The following document was submitted to the FDA by the labeler of this product Filo America. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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