Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 0869-0602-10, 0869-0602-34, 0869-0602-43, 0869-0602-45
- Packager: Vi-Jon, LLC
- 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 December 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- WARNINGS
- Ask a Doctor before use
- 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 liquie 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
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
Epsom Salt
MAGNESIUM SULFATE U.S.P.Tamper Evident Packaging:
Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilatedFor 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 towelling for 30 minutes up to three times a day, or use as a soak or in 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.
Distributed by Vi-Jon, LLC
One Swan Drive
Smyrna, TN 37167
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principal display panel
Mountain Falls
Naturally derived
For a soothing, relaxing bath, add to warm bath
Reduce stiffness and soreness
Warm and comfort your muscle aches
Epsom Salt
magnesium sulfate USP
saline laxative for relief of occasional constipation
soaking aid for minor sprains and bruises
NET WT 1 LB (454 g)
www.mymountainfalls.com
- 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:0869-0602 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:0869-0602-43 454 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1998 2 NDC:0869-0602-10 1814 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1998 3 NDC:0869-0602-45 907 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1998 4 NDC:0869-0602-34 227 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/15/1998 Labeler - Vi-Jon, LLC (790752542) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0869-0602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0869-0602)
