Label: PROALLER- ailanthus altissima whole, okoubaka aubrevillei bark, euphrasia stricta, gratiola officinalis, juglans regia whole, smilax regelii root, and taraxacum officinale whole solution/ drops

  • NDC Code(s): 59469-116-10
  • Packager: PEKANA Naturheilmittel
  • 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 December 19, 2022

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  • ACTIVE INGREDIENT

    Ingredients:
    Ailanthus altissima4X
    Euphrasia officinalis3X
    Gratiola officinalis4X
    Juglans regia6X
    Okoubaka aubrevillei3X
    Smilax (Sarsaparilla)8X
    Taraxacum officinale12X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 28% alcohol by volume.

  • Indications

    For temporary relief of allergies and hay fever symptoms. 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

    PROALLER™
    Oral Drops

    Homeopathic Medicine

    For temporary relief
    of allergies and
    hay fever symptoms

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    PROALLER 
    ailanthus altissima whole, okoubaka aubrevillei bark, euphrasia stricta, gratiola officinalis, juglans regia whole, smilax regelii root, and taraxacum officinale whole solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ailanthus altissima Whole (UNII: 5G78C6GB5E) (Ailanthus altissima Whole - UNII:5G78C6GB5E) Ailanthus altissima Whole4 [hp_X]  in 50 mL
    Okoubaka aubrevillei Bark (UNII: MK2074187Z) (Okoubaka aubrevillei Bark - UNII:MK2074187Z) Okoubaka aubrevillei Bark3 [hp_X]  in 50 mL
    Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL) Euphrasia Stricta3 [hp_X]  in 50 mL
    GRATIOLA OFFICINALIS WHOLE (UNII: BDD9991A36) (GRATIOLA OFFICINALIS WHOLE - UNII:BDD9991A36) GRATIOLA OFFICINALIS WHOLE4 [hp_X]  in 50 mL
    Juglans regia Whole (UNII: 87EJ76IO83) (Juglans regia Whole - UNII:87EJ76IO83) Juglans regia Whole6 [hp_X]  in 50 mL
    Smilax Ornata Root (UNII: 2H1576D5WG) (Smilax Ornata Root - UNII:2H1576D5WG) Smilax Ornata Root8 [hp_X]  in 50 mL
    Taraxacum officinale Whole (UNII: 7C42E2D7B0) (Taraxacum Officinale Whole - UNII:7C42E2D7B0) Taraxacum officinale Whole12 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-116-101 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 (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel320344542MANUFACTURE(59469-116)
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