IMMUNE WAKER - influenza a virus, rancid beef, bacillus anthracis immunoserum rabbit, arnica montana, atropa belladonna, lytta vesicatoria, aconitum napellus, arsenic trioxide, baptisia tinctoria root, bryonia alba root, calcium sulfide, iodine, lachesis muta venom, mercury, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, apis mellifera, echinacea, unspecified, goldenseal, thuja occidentalis leafy twig and influenza b virus liquid 
Newton Laboratories, Inc.

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.

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Immune Waker

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: EXTERNAL USE ONLY.   Ages 12 and up, take 6 drops orally (ages 0 to11, give 3 drops) three to four times daily or as directed by a healthcare professional.

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: 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.

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
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. liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Influenza A Virus (Influenza A Virus) Influenza A Virus30 [hp_X]  in 1 mL
Rancid Beef (Rancid Beef) Rancid Beef30 [hp_X]  in 1 mL
Bacillus Anthracis Immunoserum Rabbit (Bacillus Anthracis Immunoserum Rabbit) Bacillus Anthracis Immunoserum Rabbit15 [hp_X]  in 1 mL
Arnica Montana (Arnica Montana) Arnica Montana15 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna15 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria15 [hp_X]  in 1 mL
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Baptisia Tinctoria Root (Baptisia Tinctoria Root) Baptisia Tinctoria Root10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Calcium Sulfide (Calcium Sulfide) Calcium Sulfide10 [hp_X]  in 1 mL
Iodine (Iodine) Iodine10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Mercury (Mercury) Mercury10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera3 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig3 [hp_X]  in 1 mL
Influenza B Virus (Influenza B Virus) Influenza B Virus30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4630-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4630-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/30/201307/01/2014
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4630)

Revised: 12/2013
Document Id: cb468e12-995d-c21e-1367-0c5feb62c433
Set id: ccc6e056-56ad-8d6b-3ad5-b7349bff5db6
Version: 2
Effective Time: 20131230
 
Newton Laboratories, Inc.