Label: LAB1796 HEADACHE EASE- atropa belladonna, cyclamen purpurascens tuber, coffee bean, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark pellet

  • 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 August 1, 2011

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  • Uses:

    For the temporary relief of migraines, tension and general headaches.

  • Active Ingredients:

    (HPUS) Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C

  • Inactive Ingredients:

    Sucrose/lactose

  • Directions:



    Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.
  • Warnings:

    If symptoms persist or worsen or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken.

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    LAB1796 HEADACHE EASE 
    atropa belladonna, cyclamen purpurascens tuber, coffee bean, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59875-4005(NDC:61727-305)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA8 [hp_C]
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER8 [hp_C]
    COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744) COFFEE BEAN4 [hp_C]
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT8 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED9 [hp_C]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_C]
    SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B) SPIGELIA MARILANDICA ROOT8 [hp_C]
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59875-4005-185 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2011
    Labeler - HomeopathyStore.com (964594324)
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