Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 55910-038-07, 55910-038-43
- Packager: Old East Main, CO
- 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 14, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
-
Directions
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
- Inactive Ingredients
- Other information
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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 mulitated.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 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 phyusician. 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.
Since 1903
Rexall
Visit us at Rexall.com or call 1-866-4-REXALL
PACKAGED FOR OLD RAST MAIN CO
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-038 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:55910-038-43 453 g in 1 POUCH; Type 0: Not a Combination Product 10/21/1993 2 NDC:55910-038-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 10/21/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/21/1993 Labeler - Old East Main, CO (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-038) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-038)
