Label: EPSOM SALTS RELIEF- magnesium sulfate heptahydrate granule

  • NDC Code(s): 22431-124-01, 22431-124-02, 22431-124-03, 22431-124-04
  • Packager: Blue Cross Laboratories, Inc.
  • 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 24, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Magnesium Sulfate [heptahydrate]100% Saline Laxative

  • PURPOSE

    -For relief of occasional constipation (irregularity)

    -this product generally produces bowel movement in 1/2 to 6 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    -For relief of occasional constipation (irregularity)

    -this product generally produces bowel movement in 1/2 to 6 hours

  • WARNINGS

    Warnings

    Ask a doctor is you have

    - kidney disease

    - a magnesium restricted diet

    - abdominal pain, nausea, or vomiting

    - noticed a sudden change in bowel habits that persists over a period of 2 weeks

    - already used a laxative for a period longer than 1 week

    Ask a doctor of pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

    If pregnant or breast-feeding, as a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    -do not exceed more than 2 doses per day

    -drink a full glass (8 ounces) of liquid with each dose

    -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 4 level teaspoons (10 to 20 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 INGREDIENT

    Other information

    Magnesium content: 495 mg per teaspoon

  • PRINCIPAL DISPLAY PANEL

    Relief

    Epsom Salt

    Magnesium Sulfate

    A Soaking aid for minor sprains & bruises

    Use as a saline laxative

    NET WT 16 Oz (1 LB) 454 g

    image of back label

    image of front label

  • INGREDIENTS AND APPEARANCE
    EPSOM SALTS  RELIEF
    magnesium sulfate heptahydrate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-124-011810 g in 1 BAG; Type 0: Not a Combination Product04/24/2015
    2NDC:22431-124-02454 g in 1 BAG; Type 0: Not a Combination Product04/24/2015
    3NDC:22431-124-03454 g in 1 CARTON; Type 0: Not a Combination Product04/24/2015
    4NDC:22431-124-04907 g in 1 BAG; Type 0: Not a Combination Product04/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/09/2010
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Blue Cross Laboratories, Inc. (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hefei Yatai Daily Chemical Products Co., Ltd.654641724manufacture(22431-124)