EPSOM SALT- magnesium sulfate granule 
Kinray, Inc.

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.


Drug Facts

Active ingredient

Magnesium Sulfate USP (epsom salt)


saline laxative

soaking solution



relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours


relieves pain from minor sprains and bruises


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.

If pregnant or breast feeding

ask a health professional before use.

keep this and all drugs out of the reach of children.

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


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

image of label


magnesium sulfate crystal granule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63777-204
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-204-01.454 kg in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/14/2012
Labeler - Kinray, Inc. (012574513)
Registrant - Aaron Industries, Inc. (030119387)
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.030119387api manufacture(63777-204), analysis(63777-204), label(63777-204)

Revised: 6/2012
Document Id: 1005d245-04bf-485a-b32c-847ea123fa3b
Set id: 5bab855c-d838-4a5e-a384-5bd939fed2e3
Version: 1
Effective Time: 20120614
Kinray, Inc.