Label: EPSOM SALT- magnesium sulfate granule
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Contains inactivated NDC Code(s)
NDC Code(s): 43221-001-04, 43221-001-16, 43221-001-19 - Packager: Frog Prince(China)Daily Chemicals Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 April 25, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before using if you are
- When using this product
- 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 more than 2 doses per day; if necessary repeat dosage in 4 hours
age dose
adults and children 2-4 level teaspoons dissolved
12 years and older in a full glass (8oz) of water
children 6 to 1-2 level teaspoons dissolved
11 years in a full glass (8oz) of water
Not recommended for children under 6 years of age
- Inactive ingredients
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43221-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM 100 g in 100 g Inactive Ingredients Ingredient Name Strength MAGNESIUM (UNII: I38ZP9992A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43221-001-19 544 g in 1 POUCH; Type 0: Not a Combination Product 09/05/2016 2 NDC:43221-001-16 454 g in 1 POUCH; Type 0: Not a Combination Product 09/05/2016 3 NDC:43221-001-04 1810 g in 1 POUCH; Type 0: Not a Combination Product 09/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/05/2016 Labeler - Frog Prince(China)Daily Chemicals Co., Ltd. (529564476)