Label: UPELVA- cyclamen purpurascens tuber, chamaelirium luteum root, hypericum perforatum, potassium carbonate, delphinium staphisagria seed, datura stramonium flowering top, viburnum opulus bark, and zanthoxylum americanum bark solution/ drops

  • NDC Code(s): 59469-319-10
  • Packager: PEKANA Naturheilmittel GmbH
  • Category: HUMAN OTC DRUG LABEL

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 12, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Ingredients:
    Cyclamen europaeum3X
    Datura stramonium (Stramonium)10X
    Delphinium staphysagria (Staphisagria)6X
    Chamaelirium luteum (Helonias dioica)4X
    Hypericum perforatum3X
    Kalium carbonicum4X
    Zanthoxylum fraxineum (Xanthoxylum fraxineum)3X
    Viburnum opulus1X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 44% alcohol by volume.

  • Indications

    For relief of minor menstrual 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

    UPELVA™

    Oral Drops

    Homeopathic Medicine

    For relief of minor
    menstrual pain

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    UPELVA 
    cyclamen purpurascens tuber, chamaelirium luteum root, hypericum perforatum, potassium carbonate, delphinium staphisagria seed, datura stramonium flowering top, viburnum opulus bark, and zanthoxylum americanum bark solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-319
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER3 [hp_X]  in 50 mL
    Chamaelirium luteum Root (UNII: DQV54Y5H3U) (Chamaelirium luteum Root - UNII:DQV54Y5H3U) Chamaelirium luteum Root4 [hp_X]  in 50 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 50 mL
    Potassium carbonate (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) Potassium carbonate4 [hp_X]  in 50 mL
    Delphinium staphisagria Seed (UNII: 00543AP1JV) (Delphinium staphisagria Seed - UNII:00543AP1JV) Delphinium staphisagria Seed6 [hp_X]  in 50 mL
    Datura stramonium Flowering Top (UNII: ESJ6ZIS34B) (Datura stramonium Flowering Top - UNII:ESJ6ZIS34B) Datura stramonium Flowering Top10 [hp_X]  in 50 mL
    Viburnum opulus Bark (UNII: T1UG6H6805) (Viburnum opulus Bark - UNII:T1UG6H6805) Viburnum opulus Bark1 [hp_X]  in 50 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-319-101 in 1 BOX06/24/2019
    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 HOMEOPATHIC06/24/2019
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-319)