Label: EPSOM SALT granule
- NDC Code(s): 49580-0394-1, 49580-0394-2, 49580-0394-4, 49580-0394-8
- Packager: P & L Development, 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.
Updated December 12, 2022
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- Active ingredient
Ask a doctor before use if you have
- kidney disease
- a magnesium restricted diet
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts more than 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
- you need to use a laxative for more than 1 week
- do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
age dose adults and children 12 years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water children 6 to 11 years
1-2 level teaspoons dissolved in a full glass (8oz) of water
Not recommended for children under 6 years of age.
- Other information
- Inactive ingredient
- Questions or comments?
- Principal Display Panel
- Package Label
INGREDIENTS AND APPEARANCE
epsom salt granule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0394 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0394-4 1814 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 2 NDC:49580-0394-1 454 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 3 NDC:49580-0394-2 907 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 4 NDC:49580-0394-8 3628 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/31/2017 Labeler - P & L Development, LLC (101896231)