Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 37012-602-07
- Packager: ShopKo Stores Operating Co., 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 14, 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 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.
-
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
- Other information
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SPL UNCLASSIFIED SECTION
To open: Cut along dotted line and press zipper to reseal
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 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.
Epsom Salt
Magnesium Sulfate USP
MgS04 7H20Packaged by Vi-Jon, LLC
One Swan Dr., Smyrna, TN 37167
2013 ShopKo Stores Operating Co., LLC
www.shopko.com
For consumer questions
call 1-888-593-0593
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-602 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:37012-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 06/05/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/05/2009 Labeler - ShopKo Stores Operating Co., LLC (023252638) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37012-602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37012-602)