Label: ENDOPLEX F (cimicifuga racemosa, fucus vesiculosus, glycyrrhiza glabra, xanthoxylum fraxineum, adrenalinum, cerebrum suis, hypophysis suis, hypothalamus (suis), oophorinum (suis), pineal (suis), thyroidinum (suis), pulsatilla- vulgaris, sepia liquid

  • NDC Code(s): 43857-0417-1
  • Packager: BioActive Nutritional, Inc.
  • 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 September 29, 2016

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  • ACTIVE INGREDIENTS:

    Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Glycyrrhiza Glabra 3X, Xanthoxylum Fraxineum 3X, Adrenalinum 8X, Cerebrum Suis 8X, Hypophysis Suis 8X, Hypothalamus (Suis) 8X, Oophorinum (Suis) 8X, Pineal (Suis) 8X, Thyroidinum (Suis) 8X, Pulsatilla (Vulgaris) 12X, Sepia 12X.

  • INDICATIONS:

    For temporary relief of menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    ENDOPLEX F

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Endoplex F

  • INGREDIENTS AND APPEARANCE
    ENDOPLEX F 
    cimicifuga racemosa, fucus vesiculosus, glycyrrhiza glabra, xanthoxylum fraxineum, adrenalinum, cerebrum suis, hypophysis suis, hypothalamus (suis), oophorinum (suis), pineal (suis), thyroidinum (suis), pulsatilla (vulgaris), sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0417
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS3 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK3 [hp_X]  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE8 [hp_X]  in 1 mL
    SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532) SUS SCROFA CEREBRUM8 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS8 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY8 [hp_X]  in 1 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND8 [hp_X]  in 1 mL
    SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID8 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0417-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/29/2016
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0417) , api manufacture(43857-0417) , label(43857-0417) , pack(43857-0417)
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