Label: TENSION HEADACHE- aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata stellaria media, verbascum thapsus, 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 May 21, 2013

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Aconitum napellus 200C, Carduus marianus 3X, Coffea cruda 200C, Dioscorea villosa 3X, Gelsemium sempervirens 3X, Gnaphalium polycephalum 3X, Iris versicolor 3X, Passiflora incarnata 2X, Stellaria media 3X, Verbascum thapsus 3X.

  • PURPOSE

    INDICATIONS:  Temporarily relieves symptoms of tension headaches: dull or sharp pain, neck and shoulder tension, feeling of pressure.

  • WARNINGS

    WARNINGS:  If symptoms persist, consult a doctor.

    If pregnant or breast feeding, ask a doctor before use.

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

    Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Adults and children over 12:  Spray twice under the tongue up to each 30 minutes as needed.  Children 12 and under:  Consult a doctor prior to use.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Organic alcohol 20% v/v, Purified water.


  • 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.


  • INDICATIONS & USAGE

    INDICATIONS:  Temporarily relieves symptoms of tension headaches:  dull or sharp pain, neck and shoulder tension, feeling of pressure.

  • QUESTIONS

    LIDDELL  LABORATORIES

    WOODBINE, IA 51579

    WWW.LIDDELL.NET  1-800-460-7733


  • PRINCIPAL DISPLAY PANEL

    ORAL SPRAYS

    LIDDELL LABORATORIES

    42

    TH

    Tension Headache

    HOMEOPATHIC

    1.0 FL. OZ. (30 ml)

    Tension Headache

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE 
    aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata stellaria media, verbascum thapsus, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50845-0058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS200 [hp_C]  in 1 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED3 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN200 [hp_C]  in 1 mL
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT3 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]  in 1 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM3 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT3 [hp_X]  in 1 mL
    STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA3 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS3 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50845-0058-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/12/2011
    Labeler - Liddell Laboratories, Inc. (832264241)
    Registrant - Liddell Laboratories, Inc. (832264241)
    Establishment
    NameAddressID/FEIBusiness Operations
    Liddell Laboratories, Inc.832264241manufacture(50845-0058)