Label: EPSOM SALT- magnesium sulfate granule
- NDC Code(s): 63777-204-01
- Packager: Kinray, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 14, 2012
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- Active ingredient
Magnesium Sulfate USP (epsom salt)Close
relieves occasional constipation (irregularity)
generally produces bowel movement in 1/2 to 6 hours
relieves pain from minor sprains and bruisesClose
ask a doctor before use if you have
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 drugClose
- when using this product
do not use more than directed.Close
- 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.Close
- 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
- INACTIVE INGREDIENT
- INGREDIENTS AND APPEARANCE
magnesium sulfate crystal granule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-204 Route of Administration ORAL, TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/14/2012 Labeler - Kinray, Inc. (012574513) Registrant - Aaron Industries, Inc. (030119387) Establishment Name Address ID/FEI Business Operations Aaron Industries, Inc. 030119387 api manufacture(63777-204) , analysis(63777-204) , label(63777-204)