Label: HEALTH SMART NATURAL EPSOM SALT- magnesium sulfate granule, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52862-200-16, 52862-200-22 - Packager: International Wholesale, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated October 28, 2013
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
- INDICATIONS & USAGE
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Warnings - Ask a doctor before use if you have:
- Kidney disease
- a magnesium restricted diet
- abdominal pain, nausea or vomiting
- noticed a sudden change in bowel habbits that persists over a period of 2 weeks
- already used a laxative for a period longer than 1 week
Ask a doctor or pharmacist before use if you are presently taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
- When using this product, do not use more than directed.
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Stop and consult a doctor if:
As Laxative:
- you have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition
- you need to use a laxative for more than 1 week
As soaking solution:
- you have redness, irritation, swelling or infection occurs
- hot or warm soaks should not be used by individuals with diabeties except with the advice of a physician
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions for Internal Use as a Laxative
- do not exceed more than 2 doses per day
- may be taken as a single daily dose or in divided doses
- dissolve each dose in a full (8 ounces) of liquid
Age Dose adults and children 12 years and older 2 to 4 level teaspoons (10 to 20 grams) daily children 6 to under 12 years 1 to 2 level teaspoons (5 to 10 grams) daily Not recomended for children under 6 years of age
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DOSAGE & ADMINISTRATION
SORE FEET RELIEF: Add one cup of HealthSmartTM Epsom Salt to one gallon of warm water and soak at least 5 minutes at a time.
BATH SOAK: Add two cups of HealthSmartTM Epsom salt under warm running bath water to release its gentle aroma. HealthSmartTM Epsom Salt helps relieve tension and provides a soothing, relaxing experience. Soak for at least 20 minutes.
First Aid Compress: Dissolve 2 cups of HealthSmart TM Epsom Salt into two cups of hot water to make a compress, apply as a wet dressing with a towel to:soothe bruises & sprains, take the sting out of insect bites, draw out splinters, alleviate pain from sports and overexertion.
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children Where promt relief is not obtained or where there is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.
EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY.
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Package Label
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INGREDIENTS AND APPEARANCE
HEALTH SMART NATURAL EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52862-200-16 454 g in 1 CARTON 2 NDC:52862-200-22 624 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/01/2013 Labeler - International Wholesale, Inc. (161872676)