Label: KALIUM SULFURICUM 6X- potassium sulfate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 July 7, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Kalium Sulphuricum (Potassium sulfate) 6X

  • PURPOSE

    Uses
    For the temporary relief of minor symptoms associated with minor skin irritation.

  • WARNINGS

    Warnings
    Do not use if you ever had an allergic reaction to this product or any of its ingredients.
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, 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 right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a
    Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if symptoms persist or worsen.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Lactose monohydrate (milk), magnesium stearate, sodium carboxymethylcellulose, xylitol

  • DOSAGE & ADMINISTRATION

    Directions
    Tip bottle slightly allowing for tablets to fall into the cap.
    Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
    Adults and adolescents (12 years and older)

    Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor symptoms associated with minor skin irritation.

    Directions
    Tip bottle slightly allowing for tablets to fall into the cap.
    Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
    Adults and adolescents (12 years and older)

    Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    UNDA

    tissue salt

    KALIUM SULFURICUM 6X

    Homeopathic Remedy

    Schüessler Salt

    For the temporary relief of minor symptoms

    associated with minor skin irritation.

    100 Tablets

    NDC 62106-1056-2

  • INGREDIENTS AND APPEARANCE
    KALIUM SULFURICUM 6X 
    potassium sulfate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1056
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM SULFATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1056-21 in 1 CARTON05/03/2018
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/03/2018
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1056)