Epsom Salt

Epsom Salt
SPL v6
SPL
SPL Set ID 40eb04d2-fcc9-4ee2-8483-99699ea7e386
Route
ORAL
Published
Effective Date 2019-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1 kg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-29

Description

Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement in 1/2 to 6 hours
Section 60561-8

Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

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
Questions

Questions or comments? 1-800-632-6900

Directions

Directions

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

  • 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.
Active Ingredient

Magnesium Sulfate

Other Information
  • Magnesium content 495 mg per teaspoon (5 grams)
Inactive Ingredients

none

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)

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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a help professional before use.

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.


Structured Label Content

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement in 1/2 to 6 hours
Section 60561-8 (60561-8)

Tamper Evident: Do not use if the heat seal at the top of the package is improperly or not fully sealed.

Purpose

Laxative

Warnings

Do No Use (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
Questions

Questions or comments? 1-800-632-6900

Directions

Directions

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

  • 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.
Active Ingredient (Active ingredient)

Magnesium Sulfate

Other Information (Other information)
  • Magnesium content 495 mg per teaspoon (5 grams)
Inactive Ingredients

none

Side Panel Information (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 (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)

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a help professional before use.

Ask A Doctor Before Use If You Have (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 (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.


Advanced Ingredient Data


Raw Label Data

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