Label: SPRAYOLOGY PMS SUPPORT- apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum, platinum metallicum, sepia, thuja occidentalis 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 March 11, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredients: Apis mellifica 200C, Chamomilla 6X, Cimicifuga racemosa 6X, Cuprum metallicum 12X, Ignatia amara 6X, Kali iodatum 200C, Magnesia phosphorica 9X, Oophorinum 30C, Platinum metallicum 12X, Sepia 9X, Thuja occidentalis 200C.

  • WARNINGS

    Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Females over 12: 2 sprays into the mouth 3 times per day or as needed when experiencing symptoms.
    • Females who are under the age of 12: please consult a health care professional.
  • PURPOSE

    Temporarily relieves common symptoms of pre-menstrual syndrome, including:

    • cramps
    • emotional fluctuations
    • fluid retention
    • irregular menstruation
  • OTHER SAFETY INFORMATION

    Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

  • INDICATIONS & USAGE

    Temporarily relieves common symptoms of pre-menstrual syndrome, including:

    ° cramps

    ° emotional fluctuations

    ° fluid retention

    ° irregular menstruation

    ° natural

    ° gluten free

    ° no artificial flavors or colors

    ° no known negative drug interactions

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPRAYOLOGY PMS SUPPORT 
    apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum, platinum metallicum, sepia, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-0031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA200 [hp_C]  in 41 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 41 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 41 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]  in 41 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]  in 41 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION200 [hp_C]  in 41 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE9 [hp_X]  in 41 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_C]  in 41 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM12 [hp_X]  in 41 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE9 [hp_X]  in 41 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]  in 41 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61096-0031-11 in 1 CARTON
    141 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/10/2014
    Labeler - Eight and Company (927364120)
    Registrant - Eight and Company (927364120)