Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 41163-602-07, 41163-602-43, 41163-602-80
- Packager: United Natural Foods, Inc. dba UNFI
- 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 May 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
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Directions
- do not exceed recommended daily dosage
- drink a full glass (8 ounces) of liquid with each dose
- may be taken as a single daily dose or in divided doses
- dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.
adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily
children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily
children under 6 years - consult a doctor
- Other information
- Inactive Ingredients
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Side Panel
- for a soothing, relaxing bath, add 1-2 cupfuls to warm bath.
- for minor sprains and bruises
- resealable pouch
For external use as a soaking aid for minor sprains and bruises
DIRECTIONS: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling for 30 minutes up to three times a day. For less intensive soak, use 1 or 2 cupfuls in a bath. Use warm water for best results.
Caution: if prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.
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Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com
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DISTRIBUTED BY SUPERVALU INC.,
EDEN PRAIRIE, MN 55344 USA
- Principal display panel
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-602 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-602-43 454 g in 1 POUCH; Type 0: Not a Combination Product 03/21/2005 2 NDC:41163-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 03/21/2005 3 NDC:41163-602-80 3629 g in 1 POUCH; Type 0: Not a Combination Product 03/21/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/21/2005 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-602)
