Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 63868-602-07, 63868-602-43
- Packager: C.D.M.A.
- 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 February 20, 2023
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 if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor
- 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
- Other information
- Inactive ingredient
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SPL UNCLASSIFIED SECTION
Tamper Evident Packaging:
Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilatedDrug Mart
EPSOM SALT
MAGNESIUM SULFATE U.S.P.
MgSO4 - 7H2OFor 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:C.D.M.A., Inc
43157 W 9 mile Rd
Novi, MI 48375
www. qualitychoice.com
Questions: 800-935-2362
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-602 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:63868-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 12/02/2019 2 NDC:63868-602-43 454 g in 1 POUCH; Type 0: Not a Combination Product 12/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/02/2019 Labeler - C.D.M.A. (011920774) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63868-602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63868-602)
