IMMUNE WAKER- influenzinum, anthracinum, arnica, belladonna, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, lycopodium, merc. viv., nux vom., phos., pulsatilla, rhus tox., apis mel., echinacea, hydrastis, thuja occ., aaricus musc,. allium sat., aloe, calc. carb., calendula, capiscum, carduus mar., salvia, selenium, taraxacum, tarentula hisp., zinc. met., zingiber liquid

Immune Waker by

Drug Labeling and Warnings

Immune Waker by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 drops by mouth (ages 0 to11, give 3 drops) three to four times daily or as directed by a health professional.

ACTIVE INGREDIENT SECTION

 Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Thuja occ. 3x, Apis mel. 8x, Echinacea 8x, Hydrastis 8x, Thuja occ. 8x, Aconitum nap. 15x, Agaricus musc. 15x, Allium sat. 15x, Aloe 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calc. carb. 15x, Calendula 15x, Capsicum 15x, Carduus mar. 15x, Hepar sulph. calc. 15x, Iodium 15x, Lachesis 15x, Lycopodium 15x, Merc. viv. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x,. Salvia 15x, Selenium 15x, Taraxacum 15x, Tarentula hisp. 15x, Zinc. met. 15x, Zingiber 15x, Anthracinum 20x, Influenzinum 35x.  

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:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

PREGNANCY OR BREAST FEEDING SECTION

 If pregnant or breast-feeding, ask a doctor before use. 

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

IMMUNE WAKER  
influenzinum, anthracinum, arnica, belladonna, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, lycopodium, merc. viv., nux vom., phos., pulsatilla, rhus tox., apis mel., echinacea, hydrastis, thuja occ., aaricus musc,. allium sat., aloe, calc. carb., calendula, capiscum, carduus mar., salvia, selenium, taraxacum, tarentula hisp., zinc. met., zingiber liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4634
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z)	Apis Mellifera	8 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	8 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV)	Goldenseal	8 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397)	Thuja Occidentalis Leafy Twig	8 [hp_X]  in 1 mL
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	15 [hp_X]  in 1 mL
Amanita Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Fruiting Body - UNII:DIF093I037)	Amanita Muscaria Fruiting Body	15 [hp_X]  in 1 mL
Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17)	Garlic	15 [hp_X]  in 1 mL
Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9)	Aloe	15 [hp_X]  in 1 mL
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW)	Arnica Montana	15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Cation (3+)	15 [hp_X]  in 1 mL
Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI)	Azadirachta Indica Bark	15 [hp_X]  in 1 mL
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU)	Baptisia Tinctoria Root	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
Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I)	Oyster Shell Calcium Carbonate, Crude	15 [hp_X]  in 1 mL
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ)	Calendula Officinalis Flowering Top	15 [hp_X]  in 1 mL
Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG)	Capsicum	15 [hp_X]  in 1 mL
Milk Thistle (UNII: U946SH95EE) (Milk Thistle - UNII:U946SH95EE)	Milk Thistle	15 [hp_X]  in 1 mL
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q)	Calcium Sulfide	15 [hp_X]  in 1 mL
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	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
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	15 [hp_X]  in 1 mL
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	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
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	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
Sage (UNII: 065C5D077J) (Sage - UNII:065C5D077J)	Sage	15 [hp_X]  in 1 mL
Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B)	Selenium	15 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375)	Taraxacum Officinale	15 [hp_X]  in 1 mL
Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT)	Lycosa Tarantula	15 [hp_X]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	15 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ)	Ginger	15 [hp_X]  in 1 mL
Bacillus Anthracis (UNII: IT7Z319PFY) (Bacillus Anthracis - UNII:IT7Z319PFY)	Bacillus Anthracis	20 [hp_X]  in 1 mL
Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E)	Influenza A Virus	35 [hp_X]  in 1 mL
Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W)	Influenza B Virus	35 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4634-1	30 mL in 1 BOTTLE, GLASS
2	NDC: 55714-4634-2	59 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/10/2014

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4634)