Label: EPSOM SALT granule
- NDC Code(s): 63868-937-04, 63868-937-16
- Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- 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 May 2, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
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
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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 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?
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Principal Display Panel
Epsom Salt
Saline Laxative
Magnesium Sulfate U.S.P.
Relieves Occasional Constipation
Soaking Aid For Minor Sprains and Bruises
Relief Throughout the Year
*Safety Sealed
Net WT LB (kg)
*TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.
Distributed by: C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48375
- Package Label
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INGREDIENTS AND APPEARANCE
EPSOM SALT
epsom salt granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-937 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:63868-937-16 454 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 12/31/2025 2 NDC:63868-937-04 1814 g in 1 POUCH; Type 0: Not a Combination Product 12/31/2017 12/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/31/2017 12/31/2025 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)