Label: DYSFUNCTIONAL BLEEDING DROPS 2138- dysfunctional bleeding drops 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Hypothalamus 6X
    Liver 6X
    Ovary 6X
    Pituitary 6X
    Spleen 6X
    Uterus 6X
    Agnus castus 8X
    Coffea tosta 8X
    Calendula officinalis 9X
    Hydrastis canadensis 9X
    Capsella bursa-pastoris 12X
    Endometritis tuberculosa 12X
    Helonias luteum 12X
    Silicea 12X
    Trifolium pratense 12X
    Viburnum opulus 12X
    Apis mellifica 30X
    Cactus grandiflorus 30X
    Collinsonia canadensis 30X
    Gelsemium sempervirens 30X
    Nux vomica 30X
    Veratrum album 30X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of occasional mild spotting or menstrual irregularity.*

  • PURPOSE

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

  • WARNINGS

    Any significant vaginal bleeding or change in menstrual pattern requires evaluation by a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

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

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Dysfunctional Bleeding Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    DYSFUNCTIONAL BLEEDING DROPS  2138
    dysfunctional bleeding drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-2138
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS6 [hp_X]  in 59 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER6 [hp_X]  in 59 mL
    BOS TAURUS OVARY (UNII: 66LZN1C747) (BOS TAURUS OVARY - UNII:66LZN1C747) BOS TAURUS OVARY6 [hp_X]  in 59 mL
    BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND, POSTERIOR - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND, POSTERIOR6 [hp_X]  in 59 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN6 [hp_X]  in 59 mL
    SUS SCROFA UTERUS (UNII: 2595C75F1P) (SUS SCROFA UTERUS - UNII:2595C75F1P) SUS SCROFA UTERUS6 [hp_X]  in 59 mL
    CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE FRUIT - UNII:433OSF3U8A) CHASTE TREE FRUIT8 [hp_X]  in 59 mL
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED8 [hp_X]  in 59 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP9 [hp_X]  in 59 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL9 [hp_X]  in 59 mL
    CAPSELLA BURSA-PASTORIS WHOLE (UNII: W0X9457M59) (CAPSELLA BURSA-PASTORIS WHOLE - UNII:W0X9457M59) CAPSELLA BURSA-PASTORIS WHOLE12 [hp_X]  in 59 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT12 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 59 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER12 [hp_X]  in 59 mL
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK12 [hp_X]  in 59 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_X]  in 59 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM30 [hp_X]  in 59 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT30 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 59 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT30 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-2138-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-2138)
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