I-Waker
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2026-01-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:04
Label at a glance#
ProductI-Waker
Active ingredientSELENIUM, TARAXACUM OFFICINALE, LYCOSA TARANTULA, ZINC, TOXICODENDRON PUBESCENS LEAF, ACONITUM NAPELLUS, INFLUENZA A VIRUS, APIS MELLIFERA, LYCOPODIUM CLAVATUM SPORE, GOLDENSEAL, THUJA OCCIDENTALIS LEAFY TWIG, AMANITA MUSCARIA FRUITING BODY, GARLIC, ALOE, ARNICA MONTANA, ARSENIC TRIOXIDE, 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, ECHINACEA, UNSPECIFIED, SAGE, INFLUENZA B VIRUS, ANEMONE PULSATILLA, AZADIRACHTA INDICA BARK, MERCURY, STRYCHNOS NUX-VOMICA SEED, GINGER, PHOSPHORUS, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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.
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 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
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 86fffa7b-d382-4771-a253-25cccb64b590 | Product name | 3 | 20251124 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
Products#
Every source-derived product name is available through these pages.
- I-Waker
- 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,
- SELENIUM
- TARAXACUM OFFICINALE
- LYCOSA TARANTULA
- ZINC
- TOXICODENDRON PUBESCENS LEAF
- ACONITUM NAPELLUS
- INFLUENZA A VIRUS
- APIS MELLIFERA
- LYCOPODIUM CLAVATUM SPORE
- GOLDENSEAL
- THUJA OCCIDENTALIS LEAFY TWIG
- AMANITA MUSCARIA FRUITING BODY
- GARLIC
- ALOE
- ARNICA MONTANA
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- 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
- WATER
- ALCOHOL
- ECHINACEA, UNSPECIFIED
- SAGE
- INFLUENZA B VIRUS
- ANEMONE PULSATILLA
- AZADIRACHTA INDICA BARK
- MERCURY
- STRYCHNOS NUX-VOMICA SEED
- GINGER
- PHOSPHORUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4838 | 55714-4838-2, 55714-4838-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 497a432d-521e-8074-e063-6394a90ae897 | 9aa07f0c-a2ac-2178-e053-2a95a90aa5d8 | 2026-01-28 | Warnings | 497a432d-521e-8074-e063-6394a90ae897 9aa07f0c-a2ac-2178-e053-2a95a90aa5d8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.