Label: MAGNESIA PHOSPHORICA 6X- magnesium hydrogen phosphate trihydrate tablet
CALCAREA CARBONICA 6X- impure calcium carbonate tablet
CALCAREA PHOSPHORICA 6X- calcium hydrogen phosphate dihydrate tablet

  • NDC Code(s): 62106-1051-2, 62106-1057-2, 62106-1062-2
  • Packager: Seroyal USA
  • 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 16, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients

    Magnesia phosphorica (Dibasic magnesium phosphate) 6X

  • PURPOSE

    Uses

    For the temporary relief of minor

    muscle cramps

    menstrual cramps

  • 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.

  • ASK DOCTOR

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • 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
    muscle cramps

    menstrual cramps

    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.


  • ACTIVE INGREDIENT

    Active ingredients

    Calcarea Carbonica (Impure Calcium Carbonate from oyster shell) 6X

  • PURPOSE

    Uses

    Helps to promote general bone and joint health.

    Support general normal growth.

  • 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 you are pregnant or breastfeeding, ask a healthcare practitioner before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • ASK DOCTOR

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

  • 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
    Helps to promote general bone and joint health.
    Support general normal growth.

    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.

  • ACTIVE INGREDIENT

    Active ingredients

    Calcium phosphoricum (calcium phosphate) 6X

  • PURPOSE

    Uses

    For the temporary relief of symptoms associated with

    minor tooth pain

    teething

  • 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 healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • ASK DOCTOR

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Lactose monohydrate (milk),

    magnesum stearate,

    sodium carboxymethlycellulose,

    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

    Indications

    For the temporary relief of symptoms associated with

    minor tooth pain

    teething

    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.

  • OTHER SAFETY INFORMATION

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

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • OTHER SAFETY INFORMATION

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

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or
    broken.
    Store in a cool, dry place.
    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • PRINCIPAL DISPLAY PANEL

    62106-1062-2

    NDC 62106-1062-2

    UNDA

    tissue salt

    CALCAREA CARBONICA 6X

    Homeopathic Remedy

    Cell Salt

    Helps to promote general bone and joint
    health, and support general normal growth.

    100 Tablets

  • PRINCIPAL DISPLAY PANEL

    62106-1057-2

    NDC 62106-1057-2

    UNDA

    tissue salt

    MAGNESIA PHOSPHORICA 6X

    Homeopathic Remedy

    Schüessler Salt

    For the temporary relief of minor
    muscle and menstrual cramps.

    100 Tablets

  • PRINCIPAL DISPLAY PANEL

    62106-1051-2

    NDC 62106-1051-2

    UNDA

    tissue salt

    CALCIUM PHOSPHORICUM 6X

    Homeopathic Remedy

    Schüessler Salt

    For the temporary relief of symptoms associated with minor tooth pain or teething.

    100 Tablets

  • INGREDIENTS AND APPEARANCE
    MAGNESIA PHOSPHORICA 6X 
    magnesium hydrogen phosphate trihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1057
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [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:62106-1057-21 in 1 CARTON01/20/2015
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2015
    CALCAREA CARBONICA 6X 
    impure calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1062
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1062-21 in 1 CARTON01/20/2015
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2015
    CALCAREA PHOSPHORICA 6X 
    calcium hydrogen phosphate dihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1051
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1051-21 in 1 CARTON01/20/2015
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1062, 62106-1051, 62106-1057)
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