Label: TOOTHACHE COMPLEX- aconitum napellus, chamomilla, hekla lava, magnesia carbonica, mezereum, phytolacca decandra, 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 June 1, 2011

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  • Purpose:

    Suggested use for one or more of the following symptoms:

    Toothache, neuralgic, drawing and shooting pains from cavity or extraction, exposure to warm or cold.

  • 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

  • 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:

    Aconitum napellus 12X, Chamomilla 6X, Hekla lava 12X, Magnesia carbonica 12X, Mezereum 12X, Phytolacca decandra 6X, Silicea 8X

  • Inactive Ingredients:

    Alcohol, 20% USP

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Toothache Complex Product


    Toothache Complex Product

    Toothache Complex Bottle Label


    Toothache Complex Bottle

    Toothache Complex Box


    Toothache Complex Box



  • INGREDIENTS AND APPEARANCE
    TOOTHACHE COMPLEX 
    aconitum napellus, chamomilla, hekla lava, magnesia carbonica, mezereum, phytolacca decandra, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52731-7044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA12 [hp_X]  in 1 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CARBONATE12 [hp_X]  in 1 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52731-7044-21 in 1 BOX
    1NDC:52731-7044-150 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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