Label: EAR COMPLEX- belladonna, calcarea carbonica, chamomilla, echinacea angustifolia, ferrum phosphoricum, hepar sulphuris calcareum, mercurius solubilis, pulsatilla 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 June 1, 2011

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  • Purpose:

    Suggested use for one or more of the following symptoms:

    Earache with deep throbbing pain,stopped up and sore ears

  • Usage and Dosage:

    For oral use only.

  • DOSAGE & ADMINISTRATION

    Adults:

        In Acute Phase:
                12-15 drops, every half hour until relief occurs
        When Relief Occurs:
                12-15 drops, 4-6 times per day

    Children 2-12 years:

                8-10 drops, 4-6 times per day

    Infants 0-24 months:

                4 drops, 4-6 times per day

  • Warnings:

    Keep out of reach of children.

  • WARNINGS

    If symptoms persist, consult a physician.

    Do not use if ring on bottom of cap is broken or missing.

  • Active Ingredients:

    Belladonna 6X, Calcarea carbonica 8X, Chamomilla 6X, Echinacea angustifolia 4X, Ferrum phosphoricum 8X, Hepar sulphuris calcareum 12X, Mercurius solubilis 8X, Pulsatilla 6X

  • Inactive Ingredients:

    Alcohol, 20% USP

  • QUESTIONS

    Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
    1-800-225-8094

  • PRINCIPAL DISPLAY PANEL

    Ear Complex Product


    Ear Complex Product

    Ear Complex Bottle Label


    Ear Complex Bottle

    Ear Complex Box


    Ear Complex Box


  • INGREDIENTS AND APPEARANCE
    EAR COMPLEX 
    belladonna, calcarea carbonica, chamomilla, echinacea angustifolia, ferrum phosphoricum, hepar sulphuris calcareum, mercurius solubilis, pulsatilla liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52731-7008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA4 [hp_X]  in 1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE8 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52731-7008-21 in 1 BOX
    1NDC:52731-7008-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Nova Homeopathic Therapeutics, Inc. (194394540)
    Registrant - Nova Homeopathic Therapeutics, Inc. (194394540)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova Homeopathic Therapeutics, Inc.194394540manufacture, label, pack
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