Label: CALCIUM COMPOSITION- arnica montana, echinacea, boron gluconate, symphytum officinale, hekla lava, calcarea carbonica liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 2, 2013

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  • ACTIVE INGREDIENTS

    Arnica Montana 3X, Echinacea 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.

  • DIRECTIONS

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

  • INACTIVE INGREDIENTS

    Demineralized Water, 25% Ethanol

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS AND USAGE

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

  • QUESTIONS

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC  29322

  • PRINCIPAL DISPLAY PANEL

    Synergy Formulas

    CALCIUM COMPOSITION

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Calcium Composition

  • INGREDIENTS AND APPEARANCE
    CALCIUM COMPOSITION 
    arnica montana, echinacea, boron gluconate, symphytum officinale, hekla lava, calcarea carbonica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0009
    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, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [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) TRIBASIC CALCIUM PHOSPHATE12 [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:43772-0009-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2013
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0009)
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