Immune Waker

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-11-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:13

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 pellets by mouth (ages 0 to11, give 3 pellets) three to four times daily or as directed by a health professional.  Under age 2, crush/dissolve pellets in purified water.

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: 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:  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
55714-4635-12020-01-31C16284748780-19d75b9d0-be57-f424-e053-dadaa90a57ceImmune Waker
55714-4635-22020-01-31C16284748780-19d75b9d0-be57-f424-e053-dadaa90a57ceImmune Waker

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4635-1Immune Waker28 g in 1 BOTTLE, GLASSPELLET281
55714-4635-2Immune Waker57 g in 1 BOTTLE, GLASSPELLET571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4635IMMUNE 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) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20141204_6fc45dc8-dead-cf55-318b-3c1b3301bf56.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
AloeACTIVE INGREDIENTV5VD430YW91
Amanita Muscaria Fruiting BodyACTIVE INGREDIENTDIF093I0371
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Azadirachta Indica BarkACTIVE INGREDIENTG580B439YI1
Bacillus AnthracisACTIVE INGREDIENTIT7Z319PFY1
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ1
CapsicumACTIVE INGREDIENT00UK7646FG1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
GarlicACTIVE INGREDIENTV1V998DC171
GingerACTIVE INGREDIENTC5529G5JPQ1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E1
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W1
IodineACTIVE INGREDIENT9679TC07X41
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Lycosa TarantulaACTIVE INGREDIENT86M454L2TT1
MercuryACTIVE INGREDIENTFXS1BY2PGL1
Milk ThistleACTIVE INGREDIENTU946SH95EE1
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
SageACTIVE INGREDIENT065C5D077J1
SeleniumACTIVE INGREDIENTH6241UJ22B1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3751
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93971
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
AloeACTIVE MOIETYV5VD430YW91
Amanita Muscaria Fruiting BodyACTIVE MOIETYDIF093I0371
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Azadirachta Indica BarkACTIVE MOIETYG580B439YI1
Bacillus AnthracisACTIVE MOIETYIT7Z319PFY1
Baptisia Tinctoria RootACTIVE MOIETY5EF0HWI5WU1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ1
CapsicumACTIVE MOIETY00UK7646FG1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
GarlicACTIVE MOIETYV1V998DC171
GingerACTIVE MOIETYC5529G5JPQ1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Influenza A VirusACTIVE MOIETYR9HH0NDE2E1
Influenza B VirusACTIVE MOIETY1314JZ2X6W1
IodineACTIVE MOIETY9679TC07X41
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Lycosa TarantulaACTIVE MOIETY86M454L2TT1
MercuryACTIVE MOIETYFXS1BY2PGL1
Milk ThistleACTIVE MOIETYU946SH95EE1
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
SageACTIVE MOIETY065C5D077J1
SeleniumACTIVE MOIETYH6241UJ22B1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Taraxacum OfficinaleACTIVE MOIETY39981FM3751
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93971
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
ZincACTIVE MOIETYJ41CSQ7QDS1
SucroseINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-463555714-4635-1, 55714-4635-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d7bea61e-c664-40ae-01ef-61d67ce788cc6fc45dc8-dead-cf55-318b-3c1b3301bf562014-11-10WarningsExact identifier
spl id: d7bea61e-c664-40ae-01ef-61d67ce788cc
spl set id: 6fc45dc8-dead-cf55-318b-3c1b3301bf56

Reported adverse events (FAERS/openFDA)#

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