Label: CALCAREA COMBINATION 9214- calcarea combination liquid

  • 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Asafoetida 4X
    Kali iodatum 4X
    Stillingia sylvatica 4X
    Calcarea phosphorica 8X
    Hekla lava 8X
    Natrum sulphuricum 8X
    Aranea diadema 9X
    Mercurius praecipitatus ruber 10X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of tender or aching bones.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

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

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    40% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Calcarea Combination

    Homeopathic Remedy

    1 FL. OZ. (29.5 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    CALCAREA COMBINATION  9214
    calcarea combination liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-9214
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN4 [hp_X]  in 29.5 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE4 [hp_X]  in 29.5 mL
    STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT4 [hp_X]  in 29.5 mL
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) ANHYDROUS DIBASIC CALCIUM PHOSPHATE8 [hp_X]  in 29.5 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA8 [hp_X]  in 29.5 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE8 [hp_X]  in 29.5 mL
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS9 [hp_X]  in 29.5 mL
    MERCURIC OXIDE (UNII: IY191986AO) (MERCURIC OXIDE - UNII:IY191986AO) MERCURIC OXIDE10 [hp_X]  in 29.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-9214-129.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-9214)