Label: PLEO RELIVORA- drosera rotundifolia, echinacea angustifolia root and english walnut solution/ drops

  • 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 November 30, 2009

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

  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

    1 fl oz
    (30 mL)

  • Indications

    For temporary relief of coughs and symptoms of bronchitis.

  • INGREDIENTS

    30 mL contains 0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X, water, ethanol (28%).

  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

  • DOSAGE

    Acute

    15 drops every two hours, up to 6 times daily.

    Chronic

    20-25 drops, 3 times daily, unless otherwise recommended by your health care professional.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Protect from light and heat.

  • SPL UNCLASSIFIED SECTION

    Made in Germany.

    Distributed by:
    SANUM USA Corp.
    1465 Slater Road
    Ferndale, WA 98248

    Manufactured By:
    Sanum-Kehlbeck
    GmbH & Co. KG

    Rev. 08/2007

  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    Pleo™ Relivora DROPS 2X , 3X, 4X

    Homeopathic Medicine

    Indications: For temporary relief of coughs and symptoms of bronchitis.

    1 fl oz (30 mL)

    DOSAGE: Acute: 15 drops every 2 hours, up to 6 times daily. Chronic: 20-25 drops, 3 times daily,
    unless otherwise recommended by your health care professional. WARNING: If symptoms persist,
    contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice
    of a health care professional before using this product. Keep this and all medications out of the
    reach of children.
    In case of accidental overdose, seek professional assistance or contact a Poison
    Control Center immediately. Protect from light and heat. TAMPER EVIDENT: Do not use this product
    if tamper-evident seal on base of bottle cap is missing or broken. INGREDIENTS: 30 mL contains:
    0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X in a base of purified
    water, ethanol (28 %).
    Rev. 06/2009

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    PLEO RELIVORA 
    drosera rotundifolia, echinacea angustifolia root and english walnut solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    drosera rotundifolia (UNII: 75O014T1HG) (drosera rotundifolia - UNII:75O014T1HG) drosera rotundifolia3 [hp_X]  in 30 mL
    echinacea angustifolia root (UNII: D982V7VT3P) (echinacea angustifolia root - UNII:D982V7VT3P) echinacea angustifolia root2 [hp_X]  in 30 mL
    english walnut (UNII: 1V3SHR7QB7) (english walnut - UNII:1V3SHR7QB7) english walnut4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-6200-31 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/31/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)