FDA.reportPublic FDA data

Immu-n Waker

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:33:38

Label at a glance#

ProductImmu-n Waker
Active ingredientSELENIUM, TARAXACUM OFFICINALE, LYCOSA TARANTULA, ZINC, TOXICODENDRON PUBESCENS LEAF, ACONITUM NAPELLUS, INFLUENZA A VIRUS, APIS MELLIFERA, LYCOPODIUM CLAVATUM SPORE, GOLDENSEAL, THUJA OCCIDENTALIS LEAFY TWIG, AMANITA MUSCARIA FRUITING BODY, GARLIC, ALOE, ARNICA MONTANA, ARSENIC TRIOXIDE, 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, ECHINACEA, UNSPECIFIED, SAGE, INFLUENZA B VIRUS, ANEMONE PULSATILLA, AZADIRACHTA INDICA BARK, MERCURY, STRYCHNOS NUX-VOMICA SEED, GINGER, PHOSPHORUS, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as hypersensitivity, debility, glandular swellings, infections and inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) three to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel 6x, Echinacea 6x, Hydrastis 6x, Thuja occ 6x, Aconitum nap 15x, Agaricus musc 15x, Allium sat 15x, Aloe 15x, Arnica 15x, Arsenicum alb 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calcarea carb 15x, Calendula 15x, Capsicum 15x, Carduus mar 15x, Hepar sulphuris calc 15x, Iodium 15x, Lachesis 15x, Lycopodium 15x, Mercurius 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 16x, Azadirachta 16x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such as hypersensitivity, debility, glandular swellings, infections and inflammation.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2596-1Immu-n Waker30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2596IMMU-N WAKER (APIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20250523_35a8381a-7fed-ab93-e063-6394a90ae3d7.zip

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
55714-259655714-2596-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SELENIUMH6241UJ22BACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
ZINCJ41CSQ7QDSACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
APIS MELLIFERA7S82P3R43ZACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
GOLDENSEALZW3Z11D0JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
GARLICV1V998DC17ACTIB
ALOEV5VD430YW9ACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAPSICUM00UK7646FGACTIB
MILK THISTLEU946SH95EEACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
SAGE065C5D077JACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
AZADIRACHTA INDICA BARKG580B439YIACTIB
MERCURYFXS1BY2PGLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
GINGERC5529G5JPQACTIB
PHOSPHORUS27YLU75U4WACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB

Source Document#

Source XML

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
Immu-n WakerAPIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUMNewton Laboratories, Inc.35a8381a-7fed-ab93-e063-6394a90ae3d72025-05-21WarningsExact identifier
ndc (package): 55714-2596-1
ndc (product): 55714-2596
ndc11 (package): 55714259601
spl id: 35a8382c-d671-ab9a-e063-6394a90acf05
spl set id: 35a8381a-7fed-ab93-e063-6394a90ae3d7

Reported adverse events (FAERS/openFDA)#

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