FEVER - INFECTION - bacillus anthracis immunoserum rabbit, influenza a virus, rancid beef, aconitum napellus, antimony potassium tartrate, arnica montana, arsenic trioxide, baptisia tinctoria, atropa belladonna, bryonia alba root, lytta vesicatoria, matricaria recutita, cinchona officinalis bark, eupatorium perfoliatum flowering top, iron, gelsemium sempervirens root, calcium sulfide, iodine, lachesis muta venom, mercury, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, salix nigra bark, verbascum thapsus, apis mellifera, echinacea, unspecified, goldenseal 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Fever - Infection  Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

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. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salix nigra 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite

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

FEVER - INFECTION  
anthracinum, influenza a virus, influenza b virus, pyrogenium, aconitum nap., antimon. tart., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chamomilla, cinchona, eupatorium perf., ferrum metallicum, gelsemium, hepar sulph.calc., iodium, lachesis, merc. viv., phosphorus, pulsatilla, rhus toxicodendron, salix nigra, verbascum, apis mel., echinacea, hydrastis liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2206
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacillus Anthracis Immunoserum Rabbit (Bacillus Anthracis Immunoserum Rabbit) Bacillus Anthracis Immunoserum Rabbit30 [hp_X]  in 1 mL
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
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus15 [hp_X]  in 1 mL
Antimony Potassium Tartrate (Antimony Cation (3+)) Antimony Potassium Tartrate15 [hp_X]  in 1 mL
Arnica Montana (Arnica Montana) Arnica Montana15 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide15 [hp_X]  in 1 mL
Baptisia Tinctoria (Baptisia Tinctoria) Baptisia Tinctoria15 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna15 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root15 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria15 [hp_X]  in 1 mL
Matricaria Recutita (Matricaria Recutita) Matricaria Recutita15 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
Eupatorium Perfoliatum Flowering Top (Eupatorium Perfoliatum Flowering Top) Eupatorium Perfoliatum Flowering Top15 [hp_X]  in 1 mL
Iron (Iron) Iron15 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
Calcium Sulfide (Calcium Sulfide) Calcium Sulfide15 [hp_X]  in 1 mL
Iodine (Iodine) Iodine15 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom15 [hp_X]  in 1 mL
Mercury (Mercury) Mercury15 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus15 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Salix Nigra Bark (Salix Nigra Bark) Salix Nigra Bark15 [hp_X]  in 1 mL
Verbascum Thapsus (Verbascum Thapsus) Verbascum Thapsus15 [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
Influenza B Virus (Influenza B Virus) Influenza B Virus30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2206-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2206-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2206-0.5 mL 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(55714-2206), API MANUFACTURE(55714-2206)

Revised: 03/2011
 
Newton Laboratories, Inc.