Label: PULSATILLA (pulsatilla- pratensis liquid

  • 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 7, 2019

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

  • ACTIVE INGREDIENT:

    (in each drop): 100% of Pulsatilla (Pratensis) 200C.

  • INDICATIONS:

    May temporarily relieve menstrual pain, irregularity, and moodiness, especially with shifting, changeable symptoms.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve menstrual pain, irregularity, and moodiness, especially with shifting, changeable symptoms.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol

  • QUESTIONS:

    Dist. by Energique, Inc.
    201 Apple Blvd.
    Woodbine, IA 51579   800.868.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    PULSATILLA

    200C

    1 fl. oz. (30 ml)

    Pulsatilla 200C

  • INGREDIENTS AND APPEARANCE
    PULSATILLA 
    pulsatilla (pratensis) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0498
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0498-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/07/2019
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0498) , api manufacture(44911-0498) , label(44911-0498) , pack(44911-0498)