Label: MENSTRUAL CRAMPS AND IRREGULARITIES- cactus grandiflorus, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, colocynthis, ipecacuanha, magnesia phosphorica, sepia, viburnum opulus, xanthoxylum fraxineum liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 23, 2015

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Cactus grandiflorus, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Colocynthis, Ipecacuanha, Magnesia phosphorica, Sepia, Viburnum opulus, Xanthoxylum fraxineum​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • 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.
    • Adults 12 and up: 3 sprays 3 times per day
    • Use additionally as needed up to 6 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
    • heavy or gushing menstruation
    • backache
    • menstrual headache
    • irregular periods
    • lack of menstrual flow
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL CRAMPS AND IRREGULARITIES 
    cactus grandiflorus, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, colocynthis, ipecacuanha, magnesia phosphorica, sepia, viburnum opulus, xanthoxylum fraxineum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0004
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0004-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/19/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0004)
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