Label: DISMEN-AID PMS- chamomilla matricaria, viburnum prunifolium, viburnum opulus, dioscorea villosa tablet

  • NDC Code(s): 34666-060-06, 34666-060-60
  • Packager: NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
  • 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 December 27, 2018

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

  • ACTIVE INGREDIENT

    Chamomilla matricaria 3x, Viburnum prunifolium 3x, Viburnum opulus 3x, Dioscorea villosa 3x

  • PURPOSE



    Chamomilla matricaria..............................irritability

    Viburnum prunifolium...................Menstrual cramps

    Viburnum opulus.........................Menstrual cramps

    Dioscorea villosa........................Menstrual cramps

  • INDICATIONS & USAGE


    Temporarily relieves symptoms associated with premenstrual syndrome (PMS) such as:

    • menstrual cramps
    • mild pain and aches
    • abdominal distention
    • irritability

    as per homeopathic materia medica

  • WARNINGS

    Do not use if you have an allergy or hypersensitivity to the components of the formula


  • ASK DOCTOR

    Ask a doctor before use if you are

    • under a doctor's care for any serious condition
    • taking any other drug
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • any new symptom appears
    • symptoms persist for more than 2 days or clear up and occur again with a few days
    • rash develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, consult a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • strong pain: adults take 1 tablet orally every 15 minutes for 2 hours
    • repeat as needed
    • do not exceed 10 tablets in 24 hours
    • as a treatment, adults take 1 tablet before each meal during 30 days
    • dissolve slowly in mouth
    • children under 12 years of age, consult your physician
  • STORAGE AND HANDLING

    store in a cool and dry place

  • INACTIVE INGREDIENT

    Gelatin, lactose, magnesium stearate, potato starch, talc

  • QUESTIONS

    Questions or comments?

    informacion@nartexlabs.com or call 1-800-839-0916 between 9am and 5pm CST

  • PRINCIPAL DISPLAY PANEL

    dismen aid pms Carton

  • INGREDIENTS AND APPEARANCE
    DISMEN-AID PMS 
    chamomilla matricaria, viburnum prunifolium, viburnum opulus, dioscorea villosa tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_X]
    VIBURNUM PRUNIFOLIUM BARK (UNII: J411UTU0HN) (VIBURNUM PRUNIFOLIUM BARK - UNII:J411UTU0HN) VIBURNUM PRUNIFOLIUM BARK3 [hp_X]
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK3 [hp_X]
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (Nartex logo) Scoreno score
    ShapeROUND (none) Size10mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-060-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product07/25/2011
    2NDC:34666-060-066 in 1 BLISTER PACK; Type 0: Not a Combination Product07/25/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/25/2011
    Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    NARTEX LABORATORIOS HOMEOPATICOS SA DE CV589914576manufacture(34666-060)