Label: OVAPLEX (angelica archangelica, caulophyllum thalictroides, dioscorea villosa, hypophysis suis, oophorinum (suis) thyroidinum- suis, uterus suis, zincum gluconicum, apis mellifica, belladonna, cimicifuga racemosa, magnesia phosphorica, sepia liquid

  • NDC Code(s): 43857-0204-1
  • 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 March 29, 2018

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

  • ACTIVE INGREDIENTS:

    Angelica Archangelica 3X, Caulophyllum Thalictroides 3X, Dioscorea Villosa 3X, Oophorinum (Suis) 6X, Hypophysis Suis 6X, Thyroidinum (Suis) 6X, Uterus Suis 6X, Zincum Gluconicum 6X, Apis Mellifica 12X, Belladonna 12X, Cimicifuga Racemosa 12X, Magnesia Phosphorica 12X, Sepia 12X.

  • INDICATIONS:

    For temporary relief of painful menses and menstrual cramps.

  • 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 a cool, dry place.

  • DIRECTIONS:

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

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • 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.

  • INDICATIONS:

    For temporary relief of painful menses and menstrual cramps.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE DISPLAY LABEL:

    BIOActive Nutritional
    HOMEOPATHIC
    OVAPLEX
    1 FL OZ (30 mL)

    Ovaplex

  • INGREDIENTS AND APPEARANCE
    OVAPLEX 
    angelica archangelica, caulophyllum thalictroides, dioscorea villosa, hypophysis suis, oophorinum (suis) thyroidinum (suis), uterus suis, zincum gluconicum, apis mellifica, belladonna, cimicifuga racemosa, magnesia phosphorica, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN) ANGELICA ARCHANGELICA ROOT3 [hp_X]  in 1 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT3 [hp_X]  in 1 mL
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER3 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY6 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND6 [hp_X]  in 1 mL
    SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID6 [hp_X]  in 1 mL
    SUS SCROFA UTERUS (UNII: 2595C75F1P) (SUS SCROFA UTERUS - UNII:2595C75F1P) SUS SCROFA UTERUS6 [hp_X]  in 1 mL
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE6 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH12 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [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:43857-0204-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0204) , api manufacture(43857-0204) , label(43857-0204) , pack(43857-0204)