Label: NATURAL EPSOM SALT- magnesium sulfate granule
- NDC Code(s): 52000-420-16, 52000-420-22
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2024
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- DRUG FACTS
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
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WARNINGS
WARNINGS - Consult 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 continues more than 2 weeks
• already used a laxative for more than 1 weekConsult a doctor or pharmacist before using if you are taking any other prescription drugs.
Laxatives may affect how other drugs work.
When using this product, DO NOT USE more than directed.
Stop use and consult a doctor if:
As Laxative:
• you have rectal bleeding or failure to have a bowel movement after use
• you need to use a laxative for more than 1 weekAs soaking solution:
• you have redness, irritation, swelling, or infection occurs
• do not use hot or warm soaks individuals with diabetes without consulting a doctorIf pregnant or breast-feeding, ask a health professional before use.
- SPL UNCLASSIFIED SECTION
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DIRECTIONS
• do not exceed more than 2 doses per day
Age Dose adults and children 12 years and older 2 to 4 level teaspoons(10 to 20 grams) dissolved in a full glass (8oz) of water children 6 to under 12 years 1 to 2 level teaspoons(5 to 10 grams) dissolved in a full glass (8oz) of water Not recommended for children under 6 years of age.
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
REGULAR UNSCENTED
• A soaking aid for minor sprains & bruises
• Use as a saline laxative
• Great for gardening
EXTERNAL USE
SORE FEET RELIEF: Add 1 cup of Epsom Salt to 1 gallon of warm water and soak for minimum 5 minutes at a time.
BATH SOAK: Add 2 cups of Epsom Salt under warm, running bath water. Soak for minimum 20 minutes to relieve tension and soothe sore tired muscles.
FIRST AID COMPRESS: Dissolve 2 cups of 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.
KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where there is evidence of infection, discontinue use and consult a doctor. Hot or warm soaks should not be used by individuals with diabetes except on advice of a doctor. AVOID CONTACT WITH EYES.
Store in a cool, dry place out of direct sunlight. Package sold by weight not volume. Some settling of content may occur during shipment. If caking occurs, tap pouch gently to free granules.
Distributed By:
Universal Distribution Center
96 Distribution Boulevard
Edison, NJ 08817
www.universaldc.com - Packaging
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INGREDIENTS AND APPEARANCE
NATURAL EPSOM SALT
magnesium sulfate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-420 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM 100 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-420-16 454 g in 1 BOX; Type 0: Not a Combination Product 11/01/2024 2 NDC:52000-420-22 623 g in 1 BOX; Type 0: Not a Combination Product 11/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 11/01/2024 Labeler - Universal Distribution Center LLC (019180459)