Label: HANGOVER HELP- agaricus musc., arsenicum alb., bismuthum metallicum, bryonia, capsicum, carbo veg., glonoinum, ipecac., iris versicolor, laurocerasus, lycopodium, mezereum, nux vom., pulsatilla, ranunc. bulb. , theridion, veratrum alb., zinc. met., zingiber, chamomilla, passiflora, valeriana 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 March 1, 2011

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

  • INDICATIONS & USAGE SECTION

    Hangover Help   Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Adults, take 6 pellets orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Agaricus musc. 15x, Arsenicum alb. 15x, Bismuthum metallicum 15x, Bryonia 15x, Capsicum 15x, Carbo veg.15x, Glonoinum 15x, Ipecac. 15x, Iris versicolor 15x, Laurocerasus 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Theridion 15x, Veratrum alb. 15x, Zinc. met. 15x, Zingiber 15x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

  • 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
    HANGOVER HELP  
    agaricus musc., arsenicum alb., bismuthum metallicum, bryonia, capsicum, carbo veg., glonoinum, ipecac., iris versicolor, laurocerasus, lycopodium, mezereum, nux vom., pulsatilla, ranunc. bulb. , theridion, veratrum alb., zinc. met., zingiber, chamomilla, passiflora, valeriana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amanita Muscaria Var. Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Var. Muscaria Fruiting Body - UNII:DIF093I037) Amanita Muscaria Var. Muscaria Fruiting Body15 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 g
    Bismuth (UNII: U015TT5I8H) (Bismuth - UNII:U015TT5I8H) Bismuth15 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 g
    Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal15 [hp_X]  in 1 g
    Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin15 [hp_X]  in 1 g
    Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac15 [hp_X]  in 1 g
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 g
    Prunus Laurocerasus Leaf (UNII: F26P2D4757) (Prunus Laurocerasus Leaf - UNII:F26P2D4757) Prunus Laurocerasus Leaf15 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 g
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 g
    Ranunculus Bulbosus (UNII: AEQ8NXJ0MB) (Ranunculus Bulbosus - UNII:AEQ8NXJ0MB) Ranunculus Bulbosus15 [hp_X]  in 1 g
    Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 g
    Veratrum Album Root (UNII: QNS6W5US1Z) (Veratrum Album Root - UNII:QNS6W5US1Z) Veratrum Album Root15 [hp_X]  in 1 g
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 g
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 g
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 g
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 g
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1113-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-1113-256.7 g in 1 BOTTLE, GLASS
    3NDC:55714-1113-07.08 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-1113)