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Headache (Newton Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 59.14 mL in 1 BOTTLE, GLASS (55714-2224-2) Label Information
LIQUID .5 mL in 1 BOTTLE, GLASS (55714-2224-0) Label Information
LIQUID 29.57 mL in 1 BOTTLE, GLASS (55714-2224-1) Label Information

Complete Headache Information

  • INDICATIONS & USAGE SECTION

    Headache  Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.


  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.


  • OTC - ACTIVE INGREDIENT SECTION

    Elaps corallinus 30x, Arsenicum alb.15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.


  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.


  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%


  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256 


  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children


  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.


  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children


  • PACKAGE LABEL

    package label


  • INGREDIENTS AND APPEARANCE
    HEADACHE  
    elaps corallinus, arsenicum alb., belladonna, bryonia, carduus benedictus, cimicifuga, coffea cruda, convallaria, crotalus horridus, digitalis, gelsemium, glonoinum, ignatia, lachesis, merc. viv., naja, nux vom., phosphorus, rhus toxicodendron, sanguinaria, secale, vipera berus, apis mel., hypericum, thuja occ.. liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2224
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom 30 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X]  in 1 mL
    Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta 15 [hp_X]  in 1 mL
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 15 [hp_X]  in 1 mL
    Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 15 [hp_X]  in 1 mL
    Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis 15 [hp_X]  in 1 mL
    Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom 15 [hp_X]  in 1 mL
    Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis 15 [hp_X]  in 1 mL
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X]  in 1 mL
    Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin 15 [hp_X]  in 1 mL
    Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 15 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X]  in 1 mL
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 15 [hp_X]  in 1 mL
    Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom 15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 15 [hp_X]  in 1 mL
    Sanguinaria Canadensis Root (UNII: N9288CD508) (Sanguinaria Canadensis Root - UNII:N9288CD508) Sanguinaria Canadensis Root 15 [hp_X]  in 1 mL
    Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium 15 [hp_X]  in 1 mL
    Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom 15 [hp_X]  in 1 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 3 [hp_X]  in 1 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 3 [hp_X]  in 1 mL
    Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig 3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-2224-1 29.57 mL in 1 BOTTLE, GLASS
    2 NDC:55714-2224-2 59.14 mL in 1 BOTTLE, GLASS
    3 NDC:55714-2224-0 .5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2224)