I-Waker

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-10-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:07:06

Label at a glance#

ProductI-Waker
Active ingredientGINGER, AMANITA MUSCARIA FRUITING BODY, SAGE, CALENDULA OFFICINALIS FLOWERING TOP, TARAXACUM OFFICINALE, SELENIUM, LYCOSA TARANTULA, ZINC, ALOE, AZADIRACHTA INDICA BARK, GARLIC, OYSTER SHELL CALCIUM CARBONATE, CRUDE, INFLUENZA A VIRUS, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, ARNICA MONTANA, ATROPA BELLADONNA, ACONITUM NAPELLUS, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, CALCIUM SULFIDE, IODINE, LACHESIS MUTA VENOM, MERCURY, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, APIS MELLIFERA, ECHINACEA, UNSPECIFIED, GOLDENSEAL, THUJA OCCIDENTALIS LEAFY TWIG, INFLUENZA B VIRUS, LYCOPODIUM CLAVATUM SPORE, CAPSICUM, MILK THISTLE
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 to11, give 3 drops) three to four times daily or as directed by a health professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel 6x, Echinacea 6x, Hydrastis 6x, Thuja occ. 6x, Aconitum nap. 15x, Agarius musc. 15x, Allium sat. 15x, Aloe 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calc. carb. 15x, Calendula 15x, Capiscum 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 15, Selenium 15x, Taraxacum 15x, Tarentula hisp. 15x, Zinc. met. 15x, Zingiber 15x, Anthracinum 16x, Azadirachta 16x, Influenzinum 30x.

PURPOSE SECTION

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.

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 labelPackage label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-482055714-4820-2

Ingredients#

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

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

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
b5a8b40f-3eb2-1429-e053-2995a90a279a951dee25-3317-49c3-e053-2a95a90a16ff2020-12-04WarningsExact identifier
spl set id: 951dee25-3317-49c3-e053-2a95a90a16ff

Reported adverse events (FAERS/openFDA)#

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