Label: PULSATILLA 30C (pulsatilla- vulgaris liquid

  • 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 January 4, 2024

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  • ACTIVE INGREDIENT:

    (in each drop) Pulsatilla 30C 100%

  • PURPOSE

    Pulsatilla 30C - moodiness**

    ** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • USES:

    May temporarily relieve: • menstrual pain • irregularity • moodiness • especially with shifting, changeable symptoms**** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    Stop use and ask a doctor if symptoms persist for more than 7 days.

    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:

    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. • Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol

  • QUESTIONS:

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

    800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    PULSATILLA

    30C

    1 fl. oz. (30 ml)

    PULSATILLA 30C
  • INGREDIENTS AND APPEARANCE
    PULSATILLA  30C
    pulsatilla (vulgaris) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0696
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0696-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/04/2024
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0696) , api manufacture(44911-0696) , label(44911-0696) , pack(44911-0696)
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