Label: MENSTRUAL CRAMPS AND IRREGULARITIES- cactus, caulophyllum, chamomilla, cimicifuga, colocynthis, ipecac, mag phos, sepia, viburnum op, xanthoxylum 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 April 10, 2018

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Cactus, Caulophyllum, Chamomilla, Cimicifuga, Colocynthis, Ipecac, Mag phos, Sepia, Viburnum op, Xanthoxylum. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

  • INDICATIONS & USAGE

    Uses ​for temporary relief of symptoms: cramps, aches and pains, abdominal bloating, irregular periods, menstrual headache, heavy or gushing menstruation, backache, lack of menstrual flow.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

  • WARNINGS

    Warnings

    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Ages 12 and up: 3 sprays 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Uses for temporary relief of symptoms:

    • cramps
    • aches and pains
    • abdominal bloating
    • irregular periods
    • menstrual headache
    • heavy or gushing menstruation,
    • backache
    • lack of menstrual flow
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL CRAMPS AND IRREGULARITIES 
    cactus, caulophyllum, chamomilla, cimicifuga, colocynthis, ipecac, mag phos, sepia, viburnum op, xanthoxylum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM10 [hp_X]  in 59 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 59 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC10 [hp_X]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK10 [hp_X]  in 59 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5004-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/10/2018
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-5004)
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