Registrants (1)

Newton Laboratories, Inc.

DUNS Number

788793610

Manufacturing Establishments (1)

Newton Laboratories, Inc.

Labeler

Newton Laboratories, Inc.

Registrant

Newton Laboratories, Inc.

DUNS Number

788793610

Products (1)

Immu-n Waker

NDC Product Code

55714-2596

Route of Administration

ORAL

Effective Date

May 21, 2025

Ingredients

Selenious acidActive

Code: H6241UJ22BClass: ACTIBQuantity: 15 [hp_X] in 1 mL

lycosa tarantulaActive

Code: 86M454L2TTClass: ACTIBQuantity: 15 [hp_X] in 1 mL

ZincActive

Code: J41CSQ7QDSClass: ACTIBQuantity: 15 [hp_X] in 1 mL

toxicodendron pubescens leafActive

Code: 6IO182RP7AClass: ACTIBQuantity: 15 [hp_X] in 1 mL

aconitum napellusActive

Code: U0NQ8555JDClass: ACTIBQuantity: 15 [hp_X] in 1 mL

lycopodium clavatum sporeActive

Code: C88X29Y479Class: ACTIBQuantity: 15 [hp_X] in 1 mL

GoldensealActive

Code: ZW3Z11D0JVClass: ACTIBQuantity: 6 [hp_X] in 1 mL

thuja occidentalis leafy twigActive

Code: 1NT28V9397Class: ACTIBQuantity: 6 [hp_X] in 1 mL

amanita muscaria fruiting bodyActive

Code: DIF093I037Class: ACTIBQuantity: 15 [hp_X] in 1 mL

GarlicActive

Code: V1V998DC17Class: ACTIBQuantity: 15 [hp_X] in 1 mL

Aloe vera leafActive

Code: V5VD430YW9Class: ACTIBQuantity: 15 [hp_X] in 1 mL

Arnica montanaActive

Code: O80TY208ZWClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Arsenic trioxideActive

Code: S7V92P67HOClass: ACTIBQuantity: 15 [hp_X] in 1 mL

baptisia tinctoria rootActive

Code: 5EF0HWI5WUClass: ACTIBQuantity: 15 [hp_X] in 1 mL

BelladonnaActive

Code: WQZ3G9PF0HClass: ACTIBQuantity: 15 [hp_X] in 1 mL

bryonia alba rootActive

Code: T7J046YI2BClass: ACTIBQuantity: 15 [hp_X] in 1 mL

CapsicumActive

Code: 00UK7646FGClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Milk thistleActive

Code: U946SH95EEClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Calcium sulfideActive

Code: 1MBW07J51QClass: ACTIBQuantity: 15 [hp_X] in 1 mL

IopromideActive

Code: 9679TC07X4Class: ACTIBQuantity: 15 [hp_X] in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

EchinaceaActive

Code: 4N9P6CC1DXClass: ACTIBQuantity: 6 [hp_X] in 1 mL

SageActive

Code: 065C5D077JClass: ACTIBQuantity: 15 [hp_X] in 1 mL

anemone pulsatillaActive

Code: I76KB35JEVClass: ACTIBQuantity: 15 [hp_X] in 1 mL

azadirachta indica barkActive

Code: G580B439YIClass: ACTIBQuantity: 16 [hp_X] in 1 mL

GingerActive

Code: C5529G5JPQClass: ACTIBQuantity: 15 [hp_X] in 1 mL

PhosphorusActive

Code: 27YLU75U4WClass: ACTIBQuantity: 15 [hp_X] in 1 mL

bacillus anthracis immunoserum rabbitActive

Code: 41LZ22DD4NClass: ACTIBQuantity: 16 [hp_X] in 1 mL

Taraxacum officinale leafActive

Code: 39981FM375Class: ACTIBQuantity: 15 [hp_X] in 1 mL

Apis mellifera venomActive

Code: 7S82P3R43ZClass: ACTIBQuantity: 6 [hp_X] in 1 mL

Influenza virus type A (H1N1)Active

Code: R9HH0NDE2EClass: ACTIBQuantity: 30 [hp_X] in 1 mL

Nux vomica extractActive

Code: 269XH13919Class: ACTIBQuantity: 15 [hp_X] in 1 mL

Ostrea edulis shellActive

Code: 2E32821G6IClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Calendula officinalis flowerActive

Code: 18E7415PXQClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Para-Mercury-Benzenesulfonic AcidActive

Code: FXS1BY2PGLClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Lachesis ExtractActive

Code: VSW71SS07IClass: ACTIBQuantity: 15 [hp_X] in 1 mL

Influenza virus type B (Victoria)Active

Code: 1314JZ2X6WClass: ACTIBQuantity: 30 [hp_X] in 1 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL

Package label

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.

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not useif tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. Ifpregnant or breast-feeding, ask a doctor before use.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - QUESTIONS SECTION

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

INACTIVE INGREDIENT SECTION

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

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Immu-n Waker

Registrants (1)

Manufacturing Establishments (1)

Products (1)

Immu-n Waker

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

WARNINGS SECTION

WARNINGS SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - QUESTIONS SECTION

QUESTIONS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION