EPSOM SALT- magnesium sulfate granule 
Kinray

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.

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Drug Facts

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.


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EPSOM SALT 
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-204
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED1.81 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
SULFIDE ION (UNII: G15I91XETI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-204-01.454 kg in 1 CARTON; Type 0: Not a Combination Product06/14/201212/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/14/201212/31/2020
Labeler - Kinray (012574513)

Revised: 11/2019
 
Kinray