EPSOM SALT- magnesium sulfate granule

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Kinray. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Magnesium Sulfate USP (epsom salt)

Purpose

saline laxative

soaking solution

Uses

Internal

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

External

relieves pain from minor sprains and bruises

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 one week

Ask a doctor or pharmacist before use 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

As a laxative,

you have rectal bleeding or no bowel movement after use .

These could be a sign of a serious condition.

you need to use a laxative more than one week.

As a soaking solution,

you have redness, irritation, swelling, or infection occurs.

hot or warm soaks should not be used by individuals with diabetes except with the advice of a physician.

Inactive ingredient

None

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Directions

For Internal Use as a laxative

Adults and Children 12 years of age and older            2-4 level teaspoons dissolved in a full glass (8oz) of water.                                                                                                                   

children 6 to under 12 years                                     1-2 level teaspoons dissolved in a full glass (8oz) of water.

not recommended for children under 6 years of age.

For External Use as a soaking solution

Adults dissolve 1/2 cup in a quart of water, and apply wet, with towel, etc.

As a bathing solution,

2 cups added to the bath water for a refreshing bath after strenuous exertion.

principal display panel

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-204
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	1.81 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
SULFIDE ION (UNII: G15I91XETI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-204-01	.454 kg in 1 CARTON; Type 0: Not a Combination Product	06/14/2012	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	06/14/2012	12/31/2020

Labeler - Kinray (012574513)