Immune Waker

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-11-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:15

Label at a glance#

ProductImmune Waker
Active ingredientApis Mellifera, Echinacea, Unspecified, Goldenseal, Thuja Occidentalis Leafy Twig, Aconitum Napellus, Amanita Muscaria Fruiting Body, Garlic, Aloe, Arnica Montana, Arsenic Trioxide, Azadirachta Indica Bark, Baptisia Tinctoria Root, Atropa Belladonna, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Calendula Officinalis Flowering Top, Capsicum, Milk Thistle, Calcium Sulfide, Iodine, Lachesis Muta Venom, Lycopodium Clavatum Spore, Mercury, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Sage, Selenium, Taraxacum Officinale, Lycosa Tarantula, Zinc, Ginger, Bacillus Anthracis, Influenza A Virus, Influenza B Virus
Label structure10 sections

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

ACTIVE INGREDIENT SECTION

OTC - 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

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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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:  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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4634-12020-01-31C16284748780-19d75b9d0-bdee-f424-e053-dadaa90a57ceImmune Waker
55714-4634-22020-01-31C16284748780-19d75b9d0-bdee-f424-e053-dadaa90a57ceImmune Waker

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4634-1Immune Waker30 mL in 1 BOTTLE, GLASSLIQUID302
55714-4634-2Immune Waker59 mL in 1 BOTTLE, GLASSLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4634IMMUNE 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 [NEWTON LABORATORIES, INC.]2Legacy NDC, 2 package rows20141212_2e8f5361-5b20-f3aa-743d-4fe0cd562959.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
AloeACTIVE INGREDIENTV5VD430YW92
Amanita Muscaria Fruiting BodyACTIVE INGREDIENTDIF093I0372
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z2
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Azadirachta Indica BarkACTIVE INGREDIENTG580B439YI2
Bacillus AnthracisACTIVE INGREDIENTIT7Z319PFY2
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q2
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ2
CapsicumACTIVE INGREDIENT00UK7646FG2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
GarlicACTIVE INGREDIENTV1V998DC172
GingerACTIVE INGREDIENTC5529G5JPQ2
GoldensealACTIVE INGREDIENTZW3Z11D0JV2
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E2
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W2
IodineACTIVE INGREDIENT9679TC07X42
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Lycosa TarantulaACTIVE INGREDIENT86M454L2TT2
MercuryACTIVE INGREDIENTFXS1BY2PGL2
Milk ThistleACTIVE INGREDIENTU946SH95EE2
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
SageACTIVE INGREDIENT065C5D077J2
SeleniumACTIVE INGREDIENTH6241UJ22B2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3752
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
ZincACTIVE INGREDIENTJ41CSQ7QDS2
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
AloeACTIVE MOIETYV5VD430YW92
Amanita Muscaria Fruiting BodyACTIVE MOIETYDIF093I0372
Apis MelliferaACTIVE MOIETY7S82P3R43Z2
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Azadirachta Indica BarkACTIVE MOIETYG580B439YI2
Bacillus AnthracisACTIVE MOIETYIT7Z319PFY2
Baptisia Tinctoria RootACTIVE MOIETY5EF0HWI5WU2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Calcium SulfideACTIVE MOIETY1MBW07J51Q2
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ2
CapsicumACTIVE MOIETY00UK7646FG2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
GarlicACTIVE MOIETYV1V998DC172
GingerACTIVE MOIETYC5529G5JPQ2
GoldensealACTIVE MOIETYZW3Z11D0JV2
Influenza A VirusACTIVE MOIETYR9HH0NDE2E2
Influenza B VirusACTIVE MOIETY1314JZ2X6W2
IodineACTIVE MOIETY9679TC07X42
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Lycosa TarantulaACTIVE MOIETY86M454L2TT2
MercuryACTIVE MOIETYFXS1BY2PGL2
Milk ThistleACTIVE MOIETYU946SH95EE2
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I2
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
SageACTIVE MOIETY065C5D077J2
SeleniumACTIVE MOIETYH6241UJ22B2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Taraxacum OfficinaleACTIVE MOIETY39981FM3752
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
ZincACTIVE MOIETYJ41CSQ7QDS2
AlcoholINACTIVE INGREDIENT3K9958V90M2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-463455714-4634-1, 55714-4634-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
575e0ba9-8135-34c4-a0c9-6920b838c90c2e8f5361-5b20-f3aa-743d-4fe0cd5629592014-11-10WarningsExact identifier
spl id: 575e0ba9-8135-34c4-a0c9-6920b838c90c
spl set id: 2e8f5361-5b20-f3aa-743d-4fe0cd562959

Reported adverse events (FAERS/openFDA)#

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