Your browser does not support JavaScript! EPSOM SALT (MAGNESIUM SULFATE CRYSTAL) GRANULE [KINRAY, INC.]
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RxNorm Names

EPSOM SALT (magnesium sulfate crystal) granule
[Kinray, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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.



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.

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

image of label

None

EPSOM SALT 
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
MAGNESIUM SULFATE (MAGNESIUM CATION) MAGNESIUM SULFATE1.81 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
SULFIDE ION 
Packaging
#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)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.030119387api manufacture(63777-204), analysis(63777-204), label(63777-204)

Revised: 6/2012
 
Kinray, Inc.

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