EPSOM SALT- magnesium sulfate granule 
Frog Prince(China)Daily Chemicals Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

EPSOM SALTS

Active Ingredient

Magnesium sulfate USP 100%

Purpose

Saline laxative

Uses

■ relieves occasional constipation (irregularity)

■ generally produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before use if you have

■ kidney disease ■ a magnesium restricted diet ■ stomach pain, nausea or vomiting ■ noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before using if you are

presently taking a prescription drug

When using this product

■ do not use more than directed

Stop use and ask a doctor if

■ you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.

■ you need to use a laxative for more than 1 week.

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

■do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours

age dose

adults and children 2-4 level teaspoons dissolved

12 years and older in a full glass (8oz) of water

children 6 to 1-2 level teaspoons dissolved

11 years in a full glass (8oz) of water

Not recommended for children under 6 years of age

Inactive ingredients

NONE

Other information

■ each teaspoon contains magnesium 493 mg

11140 EPSOM SALT

EPSOM SALT 
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43221-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM (UNII: I38ZP9992A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43221-001-19544 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
2NDC:43221-001-16454 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
3NDC:43221-001-041810 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/05/2016
Labeler - Frog Prince(China)Daily Chemicals Co., Ltd. (529564476)

Revised: 4/2020
Document Id: f357f581-e4be-4909-bc15-c4d7156dfa1d
Set id: 3d19523d-7cc3-2f2f-e054-00144ff88e88
Version: 5
Effective Time: 20200425
 
Frog Prince(China)Daily Chemicals Co., Ltd.