Label: COMBINATION REMEDY 10 - MENSTRUAL PAIN- aesculus hipposcastanum, caulophyllum, crocus sativus, ferrum phosphoricum , hamamelis virginiana, kali phosphoricum, pulsatilla, secale cornutum solution/ drops

  • 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 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

    If pregnant or breast-feeding, ask health professional before use.

    Do not use if tamper evident seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Aesculus Hipposcastanum 2X

    Caulophyllum 2X

    Crocus Sativus 4X

    Ferrum Phosphoricum 6X

    Hamamelis Virginiana 6X

    Kali Phosphoricum 6X

    Pulsatilla 2X

    Secale Cornutum 6X

  • PURPOSE

    Temporary relief from menstrual cramps, pain, irregular periods.

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

    Children under 12 years: Not intended for use by children under 12.

  • INDICATIONS & USAGE

    Temporary relief from menstrual cramps, pain, irregular periods.

  • PRINCIPAL DISPLAY PANEL

    menstrual pain combo 10.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 10 - MENSTRUAL PAIN 
    aesculus hipposcastanum, caulophyllum, crocus sativus, ferrum phosphoricum , hamamelis virginiana, kali phosphoricum, pulsatilla, secale cornutum solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAFFRON (UNII: E849G4X5YJ) (SAFFRON - UNII:E849G4X5YJ) SAFFRON4 [hp_X]  in 1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM6 [hp_X]  in 1 mL
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT2 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 1 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM6 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS2 [hp_X]  in 1 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT2 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4010-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772manufacture(69008-4010) , pack(69008-4010) , label(69008-4010)
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