Label: IMMUNE WAKER- influenzinum, pyrogenium, anthracinum,arnica, belladonna, cantharis, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, merc. viv., nux vom., phosphorus, pulsatilla, rhus toxicodendron, apis mel., echinacea, hydrastis, thuja occ. plaster

  • Category: HUMAN PRESCRIPTION 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 30, 2013

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with a compromised immune system such as hypersensitivity, debility, glandular swellings, infections and inflammation.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to11, give 3 pellets) three to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

  • ACTIVE INGREDIENT SECTION

    Influenzinum 30x, Pyrogenium 30x, Anthracinum 15x, Arnica 15x, Belladonna 15x, Cantharis 15x, Aconitum nap. 10x, Arsenicum alb.10x, Baptisia 10x, Bryonia 10x, Hepar sulph. calc. 10x, Iodium 10x, Lachesis 10x, Merc. viv. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Thuja occ. 3x. 

  • PURPOSE SECTION

    Formulated for symptoms associated with a compromised immune system such as hypersensitivity, debility, glandular swellings, infections and inflammation.

  • 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.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    IMMUNE WAKER  
    influenzinum, pyrogenium, anthracinum,arnica, belladonna, cantharis, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, merc. viv., nux vom., phosphorus, pulsatilla, rhus toxicodendron, apis mel., echinacea, hydrastis, thuja occ. plaster
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4631
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E) Influenza A Virus30 [hp_X]  in 1 g
    Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU) Rancid Beef30 [hp_X]  in 1 g
    Bacillus Anthracis Immunoserum Rabbit (UNII: 41LZ22DD4N) (Bacillus Anthracis Immunoserum Rabbit - UNII:41LZ22DD4N) Bacillus Anthracis Immunoserum Rabbit15 [hp_X]  in 1 g
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 g
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 g
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 g
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus10 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
    Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root10 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide10 [hp_X]  in 1 g
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine10 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury10 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 g
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 g
    Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig3 [hp_X]  in 1 g
    Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W) Influenza B Virus30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4631-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4631-256.7 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/30/2013
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4631)
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