Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 36800-602-07, 36800-602-43
- Packager: TOPCO Associates, 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 16, 2022
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- Official Label (Printer Friendly)
- 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
Directions for Soaking
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.
- inactive ingredients
- Other information
- ADVERSE REACTIONS
- 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:36800-602 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:36800-602-43 454 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1999 2 NDC:36800-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 07/15/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/15/1999 Labeler - TOPCO Associates, LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-602)