Label: DYSMENORREX- chamomilla, magnesia phosphorica, murex purpurea, platinum metallicum, viburnum opulus spray

  • 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 13, 2017

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

  • HPUS Active Ingredients:

    Equal volumes of each ingredient in a 6C potency: Chamomilla, Magnesia phosphorica, Murex purpurea, Platinum metallicum, Viburnum opulus.

  • Uses*:

    Homeopathic remedy to help soothe and reduce menstrual cramps and period pains.

    *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

  • Warnings:

    If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions:

    Initally, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily until symptoms improve. Adults and children 12+: 3 pump sprays.

  • OTHER SAFETY INFORMATION

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

  • Inactive Ingredients:

    Citric acid, potassium sorbate, purified water.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • PURPOSE

    Soothes menstrual cramps & period pains

  • PRINCIPAL DISPLAY PANEL

    Dysmenorrex

  • INGREDIENTS AND APPEARANCE
    DYSMENORREX 
    chamomilla, magnesia phosphorica, murex purpurea, platinum metallicum, viburnum opulus spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-297
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK6 [hp_C]  in 59 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM6 [hp_C]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC6 [hp_C]  in 59 mL
    HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y) HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE6 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-297-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/08/2017
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-297) , api manufacture(68703-297)