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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  • Active ingredient

    Magnesium sulfate USP 100%

  • Purpose

     Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • 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

    Ask a doctor or pharmacist before use if you are

     presently taking a prescription drug.

    When using this product

    • do not use more than directed

    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

    If pregnancy or breast-feeding,

     ask a health professional before use.

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
    agedose
     adults and children 12  years and older2-4 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

    • each teaspoon contains: magnesium 495 mg
  • Inactive ingredient

    none 

  • Questions or comments?

    For laxative or soak, call 1-248-449-9300 Monday- Friday 9AM-5PM EST

  • 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

    www.qualitychoice.com

  • Package Label

    Magnesium Sulfate USP 100%

    QUALITY CHOICE Epsom Salt

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT 
    epsom salt granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-937
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-937-16454 g in 1 POUCH; Type 0: Not a Combination Product12/31/201712/31/2025
    2NDC:63868-937-041814 g in 1 POUCH; Type 0: Not a Combination Product12/31/201712/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/31/201712/31/2025
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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