Label: APO-DOLOR- aconitum napellus, semecarpus anacardium fruit, bryonia dioica root, gelsemium sempervirens root, menyanthes trifoliata, piper methysticum root, schoenocaulon officinale seed, and spigelia anthelmia solution/ drops

  • NDC Code(s): 59469-130-10
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 2, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ingredients:
    Aconitum napellus12X
    Bryonia cretica3X
    Gelsemium sempervirens4X
    Menyanthes trifoliata3X
    Piper methysticum8X
    Schoenocaulon officinale (Sabadilla)3X
    Semecarpus anacardium6X
    Spigelia anthelmia3X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 40% alcohol by volume.

  • Indications

    For relief of minor headaches, and muscle pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®
    GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

    apo-DOLOR

    Oral Drops

    Homeopathic Medicine

    For relief of
    minor headaches,
    and muscle pain

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    APO-DOLOR 
    aconitum napellus, semecarpus anacardium fruit, bryonia dioica root, gelsemium sempervirens root, menyanthes trifoliata, piper methysticum root, schoenocaulon officinale seed, and spigelia anthelmia solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus12 [hp_X]  in 50 mL
    Semecarpus anacardium Fruit (UNII: 7399B063X9) (Semecarpus anacardium Fruit - UNII:7399B063X9) Semecarpus anacardium Fruit6 [hp_X]  in 50 mL
    Bryonia Dioica Root (UNII: 53UB5FH7CX) (Bryonia Dioica Root - UNII:53UB5FH7CX) Bryonia Dioica Root3 [hp_X]  in 50 mL
    Gelsemium sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium sempervirens Root - UNII:639KR60Q1Q) Gelsemium sempervirens Root4 [hp_X]  in 50 mL
    Menyanthes trifoliata (UNII: 7H0QTZ446K) (Menyanthes trifoliata - UNII:7H0QTZ446K) Menyanthes trifoliata3 [hp_X]  in 50 mL
    Macropiper Methysticum Root (UNII: BOW48C81XP) (Macropiper Methysticum Root - UNII:BOW48C81XP) Macropiper Methysticum Root8 [hp_X]  in 50 mL
    Schoenocaulon officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon officinale Seed3 [hp_X]  in 50 mL
    Spigelia Anthelmia (UNII: WYT05213GE) (Spigelia Anthelmia - UNII:WYT05213GE) Spigelia Anthelmia3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-130-101 in 1 BOX12/11/2008
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/11/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-130)