ROYAL EPSOM SALT- magnesium sulfate granule, for solution 
Filo America

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Epsom Salt

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

Warnings

Do no use

Ask a doctor before use if you have

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

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

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)

FrontBack

ROYAL EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM1 kg  in 1 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-001-001.8 kg in 1 BAG; Type 0: Not a Combination Product10/29/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00710/29/2014
Labeler - Filo America (943873703)
Establishment
NameAddressID/FEIBusiness Operations
Hefei Yatai Daily-Use Chemical Industry Co., Ltd654641724manufacture(50438-001)

Revised: 10/2023
Document Id: 08c11030-7bab-55ae-e063-6394a90a1437
Set id: 40eb04d2-fcc9-4ee2-8483-99699ea7e386
Version: 5
Effective Time: 20231028
 
Filo America