FDA.reportPublic FDA data

I-Waker

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:08:54

Label at a glance#

ProductI-Waker
Active ingredientBAPTISIA 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, INFLUENZA B VIRUS, GARLIC, ANEMONE PULSATILLA, AZADIRACHTA INDICA BARK, MERCURY, STRYCHNOS NUX-VOMICA SEED, GINGER, PHOSPHORUS, SAGE, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, SELENIUM, TARAXACUM OFFICINALE, LYCOSA TARANTULA, ZINC, TOXICODENDRON PUBESCENS LEAF, INFLUENZA A VIRUS, APIS MELLIFERA, LYCOPODIUM CLAVATUM SPORE, GOLDENSEAL, THUJA OCCIDENTALIS LEAFY TWIG, ACONITUM NAPELLUS, AMANITA MUSCARIA FRUITING BODY, ALOE, ARNICA MONTANA, ARSENIC TRIOXIDE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated 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 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

Formulated for associated 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

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
55714-256055714-2560-2, 55714-2560-1

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
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
INFLUENZA B VIRUS1314JZ2X6WACTIB
GARLICV1V998DC17ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
AZADIRACHTA INDICA BARKG580B439YIACTIB
MERCURYFXS1BY2PGLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
GINGERC5529G5JPQACTIB
PHOSPHORUS27YLU75U4WACTIB
SAGE065C5D077JACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
SELENIUMH6241UJ22BACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
ZINCJ41CSQ7QDSACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
APIS MELLIFERA7S82P3R43ZACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
GOLDENSEALZW3Z11D0JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
ALOEV5VD430YW9ACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB

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
3594bdbf-ea3b-430b-e063-6294a90a5e279e5211ed-84b4-55ba-e053-2995a90a36d62025-05-20WarningsExact identifier
spl set id: 9e5211ed-84b4-55ba-e053-2995a90a36d6

Reported adverse events (FAERS/openFDA)#

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