ROYAL EPSOM SALT- magnesium sulfate granule, for solution

ROYAL Epsom Salt by

Drug Labeling and Warnings

ROYAL Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Filo America, Hefei Yatai Daily-Use Chemical Industry Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTHER SAFETY INFORMATION

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

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)

INGREDIENTS AND APPEARANCE

ROYAL EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED FORM	1 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-001-00	1.8 kg in 1 BAG; Type 0: Not a Combination Product	10/29/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/29/2014

Labeler - Filo America (943873703)

Establishment
Name	Address	ID/FEI	Business Operations
Hefei Yatai Daily-Use Chemical Industry Co., Ltd		654641724	manufacture(50438-001)