EPSOM SALT- magnesium sulfate granule

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Frog Prince(China)Daily Chemicals Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Label

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43221-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43221-001-19	544 g in 1 POUCH; Type 0: Not a Combination Product	09/05/2016
2	NDC: 43221-001-16	454 g in 1 POUCH; Type 0: Not a Combination Product	09/05/2016
3	NDC: 43221-001-04	1810 g in 1 POUCH; Type 0: Not a Combination Product	09/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/05/2016

Labeler - Frog Prince(China)Daily Chemicals Co., Ltd. (529564476)