CALCAREA SULFURICA 6X (CALCIUM SULFATE) TABLET [SEROYAL USA]

CALCAREA SULFURICA 6X (CALCIUM SULFATE) TABLET [SEROYAL USA]
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NDC 62106-1052-2
Set ID 58250ce3-b476-493e-e053-2a91aa0a4fef
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredients
    Calcarea sulphurica (Calcium sulfate) 6X

  • PURPOSE

    For the temporary relief of symptoms associated with

    skin irritation

    tender gums

  • 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.

  • 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

  • PREGNANCY OR BREAST FEEDING

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

  • 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 symptoms associated with

    skin irritation

    tender gums

    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

    CALCAREA SULFURICA 6X

    UNDA

    tissue salt

    CALCAREA SULFURICA 6X

    Homeopathic Remedy

    Schuessler Salt

    For the temporary relief of symptoms associated with skin irritation and tender gum.

    100 Tablets

  • INGREDIENTS AND APPEARANCE
    CALCAREA SULFURICA 6X 
    calcium sulfate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1052
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1052-21 in 1 CARTON09/01/2017
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2017
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1052)

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