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I-Waker

I-Waker 4838L

Approved
Approval ID

9aa07f0c-a2ac-2178-e053-2a95a90aa5d8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Apis mellifica, Echinacea, Hydrastis canadensis, Thuja occidentalis, Aconitum napellus, Agaricus muscarius, Allium sativum, Aloe, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calcarea carbonica, Calendula officinalis, Capsicum annuum, Carduus marianus, Hepar sulphuris calcareum, Iodium, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Selenium metallicum, Taraxacum officinale, Tarentula hispana,

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-4838
Product Classification
G
Generic Name
Apis mellifica, Echinacea, Hydrastis canadensis, Thuja occidentalis, Aconitum napellus, Agaricus muscarius, Allium sativum, Aloe, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calcarea carbonica, Calendula officinalis, Capsicum annuum, Carduus marianus, Hepar sulphuris calcareum, Iodium, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Selenium metallicum, Taraxacum officinale, Tarentula hispana,
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (38)

SELENIUMActive
Quantity: 15 [hp_X] in 1 mL
Code: H6241UJ22B
Classification: ACTIB
LYCOSA TARANTULAActive
Quantity: 15 [hp_X] in 1 mL
Code: 86M454L2TT
Classification: ACTIB
ZINCActive
Quantity: 15 [hp_X] in 1 mL
Code: J41CSQ7QDS
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 15 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 15 [hp_X] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 15 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
GOLDENSEALActive
Quantity: 6 [hp_X] in 1 mL
Code: ZW3Z11D0JV
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
AMANITA MUSCARIA FRUITING BODYActive
Quantity: 15 [hp_X] in 1 mL
Code: DIF093I037
Classification: ACTIB
GARLICActive
Quantity: 15 [hp_X] in 1 mL
Code: V1V998DC17
Classification: ACTIB
ALOEActive
Quantity: 15 [hp_X] in 1 mL
Code: V5VD430YW9
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 15 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
BAPTISIA TINCTORIA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 15 [hp_X] in 1 mL
Code: WQZ3G9PF0H
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
CAPSICUMActive
Quantity: 15 [hp_X] in 1 mL
Code: 00UK7646FG
Classification: ACTIB
MILK THISTLEActive
Quantity: 15 [hp_X] in 1 mL
Code: U946SH95EE
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: 1MBW07J51Q
Classification: ACTIB
IODINEActive
Quantity: 15 [hp_X] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ECHINACEA, UNSPECIFIEDActive
Quantity: 6 [hp_X] in 1 mL
Code: 4N9P6CC1DX
Classification: ACTIB
SAGEActive
Quantity: 15 [hp_X] in 1 mL
Code: 065C5D077J
Classification: ACTIB
ANEMONE PULSATILLAActive
Quantity: 15 [hp_X] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
AZADIRACHTA INDICA BARKActive
Quantity: 16 [hp_X] in 1 mL
Code: G580B439YI
Classification: ACTIB
GINGERActive
Quantity: 15 [hp_X] in 1 mL
Code: C5529G5JPQ
Classification: ACTIB
PHOSPHORUSActive
Quantity: 15 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBITActive
Quantity: 16 [hp_X] in 1 mL
Code: 41LZ22DD4N
Classification: ACTIB
TARAXACUM OFFICINALEActive
Quantity: 15 [hp_X] in 1 mL
Code: 39981FM375
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 15 [hp_X] in 1 mL
Code: 2E32821G6I
Classification: ACTIB
APIS MELLIFERAActive
Quantity: 6 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 15 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB
INFLUENZA A VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: R9HH0NDE2E
Classification: ACTIB
MERCURYActive
Quantity: 15 [hp_X] in 1 mL
Code: FXS1BY2PGL
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 15 [hp_X] in 1 mL
Code: 18E7415PXQ
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 15 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB
INFLUENZA B VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: 1314JZ2X6W
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/30/2020

PACKAGE LABEL

package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/30/2020

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/30/2020

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/30/2020

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Thuja occidentalis 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium sativum 15x, Aloe 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calcarea carbonica 15x, Calendula officinalis 15x, Capsicum annuum 15x, Carduus marianus 15x, Hepar sulphuris calcareum 15x, Iodium 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salvia officinalis 15x, Selenium metallicum 15x, Taraxacum officinale 15x, Tarentula hispana 15x, Zincum metallicum 15x, Zingiber officinale 15x, Anthracinum 16x, Azadirachta indicia 16x, Influenzinum 30x.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/30/2020

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/30/2020

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/30/2020

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

WARNINGS SECTION

LOINC: 34071-1Updated: 6/30/2020

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/30/2020

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/30/2020

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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I-Waker - FDA Drug Approval Details