Label: HEADACHE RELIEF- atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark pellet

  • NDC Code(s): 61727-305-21
  • Packager: Homeocare Laboratories
  • 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 26, 2018

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  • Active Ingredients:

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

  • Inactive Ingredients:

    Sucrose/lactose.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Purpose:

    Temporarily relieves migraines, tension and general headaches.

  • Warnings:

    If pregnant or nursing, or if symptoms persist, worsen or if fever, nausea or vomiting are present, consult a doctor promptly. Keep out of reach of children. Do not use if cap seal is broken or missing.

  • Indications & Usage:

    Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

  • Dosage & Administration:

    Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

  • Headache Relief

    hcl_label_headache 2012.jpg

  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF 
    atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, 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:61727-305
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA8 [hp_C]  in 4 g
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER8 [hp_C]  in 4 g
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED4 [hp_C]  in 4 g
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT8 [hp_C]  in 4 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED9 [hp_C]  in 4 g
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_C]  in 4 g
    SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B) SPIGELIA MARILANDICA ROOT8 [hp_C]  in 4 g
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK4 [hp_C]  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61727-305-214 g in 1 TUBE; Type 0: Not a Combination Product07/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/20/2012
    Labeler - Homeocare Laboratories (088248828)
    Registrant - Homeocare Laboratories (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories088248828manufacture(61727-305)
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