Label: HELONIAS COMBINATION 9227- helonias combination 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

    Viburnum opulus 2X
    Apis mellifica 4X
    Cimicifuga racemosa 4X
    Lilium tigrinum 4X
    Lycopodium clavatum 4X
    Melilotus officinalis 4X
    Pulsatilla 4X
    Vespa crabro 4X
    Helonias dioica 6X
    Ammonium bromatum 8X
    Aurum iodatum 12X
    Chlamydia 12X
    Lachesis mutus 12X
    Mercurius corrosivus 12X
    Naja tripudians 12X
    Palladium metallicum 12X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of mild to moderate pain, inflammation, nausea, or occasional headache associated with dysmenorrhea.*

  • PURPOSE

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

  • WARNINGS

    In case of overdose, get medical help or contact a poison control center right away.

    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

    40% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Helonias Combination

    Homeopathic Remedy

    1 FL. OZ. (29.5 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    HELONIAS COMBINATION  9227
    helonias combination liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-9227
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK2 [hp_X]  in 29.5 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA4 [hp_X]  in 29.5 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 29.5 mL
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING4 [hp_X]  in 29.5 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE4 [hp_X]  in 29.5 mL
    MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP4 [hp_X]  in 29.5 mL
    PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (PULSATILLA MONTANA WHOLE - UNII:24K790T39B) PULSATILLA MONTANA WHOLE4 [hp_X]  in 29.5 mL
    VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H) VESPA CRABRO4 [hp_X]  in 29.5 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT6 [hp_X]  in 29.5 mL
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE8 [hp_X]  in 29.5 mL
    GOLD MONOIODIDE (UNII: T1UDV7ES1A) (GOLD MONOIODIDE - UNII:T1UDV7ES1A) GOLD MONOIODIDE12 [hp_X]  in 29.5 mL
    CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (CHLAMYDIA TRACHOMATIS - UNII:T6NI39QU44) CHLAMYDIA TRACHOMATIS12 [hp_X]  in 29.5 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 29.5 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE12 [hp_X]  in 29.5 mL
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM12 [hp_X]  in 29.5 mL
    PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM12 [hp_X]  in 29.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-9227-129.5 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(63083-9227)
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