Label: CALC SULPH 12X tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 27, 2020

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  • ACTIVE INGREDIENT

    Calcarea Sulphurica 12X

  • INACTIVE INGREDIENT

    Lactose

  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

    Do not use if tamper evident seal is missing or broken.

  • INDICATIONS & USAGE

    Temporary relief from boils, pimples, dry itchy skin, pus.

  • PURPOSE

    Temporary relief from boils, pimples, dry itchy skin, pus.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Four tablets every thirty minutes for six doses followed by four tablets every 4-6 hours as needed.

    Children 2 years to 12 years of age: Four tablets every thirty minutes for six doses followed by two tablets every 4-6 hours as needed.

    Children under 2 years of age: Consult doctor prior to use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    calc sulph 12.jpg

  • INGREDIENTS AND APPEARANCE
    CALC SULPH 12X 
    calc sulph 12x tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79718-0012(NDC:79769-0012)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code SBL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79718-0012-1900 in 1 JAR; Type 0: Not a Combination Product11/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2020
    Labeler - Warsan Homeopathic (081031642)
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