Label: CALCIUM COMPOSITION (arnica montana, echinacea- angustifolia, boron glucconate, symphytum officinale, hekla lava, calcarea carbonica, clacarea fluorica, calcarea phosphorica, lycopodium clavatum, silicea. 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 July 16, 2014

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  • ACTIVE INGREDIENTS:

    Arnica Montana 3X, Echinacea (Angustifolia) 3X, Boron Gluconate 6X, 12X, Symphytum Officinale 6X, 30X, Hekla Lava 8X, 30X, Calcarea Carbonica 12X, 30X, Calcarea Fluorica 12X, 30X, Calcarea Phosphorica 12X, 30X, Lycopodium Clavatum 12X, 30X, Silicea 12X, 30X, 200X

  • INDICATIONS:

    Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.

  • WARNINGS:

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

    If pregnant or breast-feeding, ask a health professional before use.

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

  • 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.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC

    251 West Road

    Campobello, SC 29322

  • PACKAGE LABEL DISPLAY:

    Synergy Formulas

    CALCIUM COMPOSITION

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Calcium Composition

  • INGREDIENTS AND APPEARANCE
    CALCIUM COMPOSITION 
    arnica montana, echinacea (angustifolia), boron glucconate, symphytum officinale, hekla lava, calcarea carbonica, clacarea fluorica, calcarea phosphorica, lycopodium clavatum, silicea. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
    BORON GLUCONATE (UNII: X8P2SY4Y7V) (BORON - UNII:N9E3X5056Q) BORON GLUCONATE6 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA8 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0037-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/16/2014
    Labeler - Synergy Formulas, Inc (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0037) , api manufacture(43772-0037) , label(43772-0037) , pack(43772-0037)
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