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

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 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

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4631
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E)	Influenza A Virus	30 [hp_X]  in 1 g
Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU)	Rancid Beef	30 [hp_X]  in 1 g
Bacillus Anthracis Immunoserum Rabbit (UNII: 41LZ22DD4N) (Bacillus Anthracis Immunoserum Rabbit - UNII:41LZ22DD4N)	Bacillus Anthracis Immunoserum Rabbit	15 [hp_X]  in 1 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW)	Arnica Montana	15 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	15 [hp_X]  in 1 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT)	Lytta Vesicatoria	15 [hp_X]  in 1 g
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	10 [hp_X]  in 1 g
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU)	Baptisia Tinctoria Root	10 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	10 [hp_X]  in 1 g
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q)	Calcium Sulfide	10 [hp_X]  in 1 g
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	10 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	10 [hp_X]  in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	10 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W)	Phosphorus	10 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	10 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A)	Toxicodendron Pubescens Leaf	10 [hp_X]  in 1 g
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z)	Apis Mellifera	3 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV)	Goldenseal	3 [hp_X]  in 1 g
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397)	Thuja Occidentalis Leafy Twig	3 [hp_X]  in 1 g
Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W)	Influenza B Virus	30 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4631-1	28.35 g in 1 BOTTLE, GLASS
2	NDC: 55714-4631-2	56.7 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/30/2013

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4631)