Immune Waker

Manufacturer: Newton Laboratories, Inc.
Effective date: 2013-12-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:05:28

Label at a glance#

ProductImmune Waker

Active ingredientInfluenza 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, Influenza B Virus

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

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

OTC - 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

OTC - 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

OTC - 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

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.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4631-1	2020-01-31	C162847	48780-1	9d75b9d0-76a2-f424-e053-dadaa90a57ce	Immune Waker
55714-4631-2	2020-01-31	C162847	48780-1	9d75b9d0-76a2-f424-e053-dadaa90a57ce	Immune Waker

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4631-1	Immune Waker	28.35 g in 1 BOTTLE, GLASS	PLASTER	28.35		2
55714-4631-2	Immune Waker	56.7 g in 1 BOTTLE, GLASS	PLASTER	56.7		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4631	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 [NEWTON LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20140211_b85e3390-fb2f-cb3c-4b2b-082202d89ea4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Aconitum Napellus	ACTIVE INGREDIENT	U0NQ8555JD	2
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	2
Arnica Montana	ACTIVE INGREDIENT	O80TY208ZW	2
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	2
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	2
Bacillus Anthracis Immunoserum Rabbit	ACTIVE INGREDIENT	41LZ22DD4N	2
Baptisia Tinctoria Root	ACTIVE INGREDIENT	5EF0HWI5WU	2
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	2
Calcium Sulfide	ACTIVE INGREDIENT	1MBW07J51Q	2
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	2
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	2
Influenza A Virus	ACTIVE INGREDIENT	R9HH0NDE2E	2
Influenza B Virus	ACTIVE INGREDIENT	1314JZ2X6W	2
Iodine	ACTIVE INGREDIENT	9679TC07X4	2
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	2
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	2
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	2
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	2
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	2
Rancid Beef	ACTIVE INGREDIENT	29SUH5R3HU	2
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	2
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	2
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	2
Aconitum Napellus	ACTIVE MOIETY	U0NQ8555JD	2
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	2
Arnica Montana	ACTIVE MOIETY	O80TY208ZW	2
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	2
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	2
Bacillus Anthracis Immunoserum Rabbit	ACTIVE MOIETY	41LZ22DD4N	2
Baptisia Tinctoria Root	ACTIVE MOIETY	5EF0HWI5WU	2
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	2
Calcium Sulfide	ACTIVE MOIETY	1MBW07J51Q	2
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	2
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	2
Influenza A Virus	ACTIVE MOIETY	R9HH0NDE2E	2
Influenza B Virus	ACTIVE MOIETY	1314JZ2X6W	2
Iodine	ACTIVE MOIETY	9679TC07X4	2
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	2
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	2
Mercury	ACTIVE MOIETY	FXS1BY2PGL	2
Phosphorus	ACTIVE MOIETY	27YLU75U4W	2
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	2
Rancid Beef	ACTIVE MOIETY	29SUH5R3HU	2
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	2
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	2
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

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.
Influenza A Virus
Rancid Beef
Bacillus Anthracis Immunoserum Rabbit
Arnica Montana
Atropa Belladonna
Lytta Vesicatoria
Aconitum Napellus
Arsenic Trioxide
Arsenic Cation (3+)
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
Sucrose
Influenza B Virus

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4631	55714-4631-1, 55714-4631-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Influenza A Virus	R9HH0NDE2E	ACTIB
Rancid Beef	29SUH5R3HU	ACTIB
Bacillus Anthracis Immunoserum Rabbit	41LZ22DD4N	ACTIB
Arnica Montana	O80TY208ZW	ACTIB
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Aconitum Napellus	U0NQ8555JD	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Baptisia Tinctoria Root	5EF0HWI5WU	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Calcium Sulfide	1MBW07J51Q	ACTIB
Iodine	9679TC07X4	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Sucrose	C151H8M554	IACT
Influenza B Virus	1314JZ2X6W	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
599bcf93-2495-7218-b15b-9b7731f2786e			b85e3390-fb2f-cb3c-4b2b-082202d89ea4	2013-12-30	Warnings	Exact identifier spl id: 599bcf93-2495-7218-b15b-9b7731f2786e spl set id: b85e3390-fb2f-cb3c-4b2b-082202d89ea4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.