Food Additives
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-11-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:13:39
Label at a glance#
ProductFood Additives
Active ingredientARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, LYCOPERDON UTRIFORME FRUITING BODY, CAFFEINE, CAPSICUM, CINCHONA OFFICINALIS BARK, CINNAMON, PROTORTONIA CACTI, CYNARA SCOLYMUS LEAF, ALPINE STRAWBERRY, GELSEMIUM SEMPERVIRENS ROOT, HISTAMINE DIHYDROCHLORIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, URTICA URENS, GINGER, MENTHA PIPERITA, ABRUS PRECATORIUS SEED, JUGLANS REGIA LEAF, USTILAGO MAYDIS, LACHESIS MUTA VENOM, NUTMEG, PODOPHYLLUM, SULFUR, ASTACUS ASTACUS, GLYCYRRHIZA GLABRA, SOLANUM TUBEROSUM, SACCHAROMYCES CEREVISIAE, LACTOSE, UNSPECIFIED FORM, SEPIA OFFICINALIS JUICE, SUCROSE, EGG SHELL, COOKED, LYCOPODIUM CLAVATUM SPORE, RHODODENDRON TOMENTOSUM LEAFY TWIG, ASCORBIC ACID, BLACK MUSTARD SEED, SOLANUM NIGRUM WHOLE, ANACARDIUM OCCIDENTALE FRUIT, SOLANUM LYCOPERSICUM, SODIUM NITRITE, SODIUM CHLORIDE, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, ALLYLTHIOUREA, IRIS VERSICOLOR ROOT, IPECAC, ACONITUM NAPELLUS, AMANITA MUSCARIA FRUITING BODY, ONION, GARLIC, PHOSPHORUS, SACCHARIN, ANTIMONY TRISULFIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium cepa 15x, Allium sativum 15x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bovista 15x, Caffeinum 15x, Capsicum annuum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Coccus cacti 15x, Cynara scolymus 15x, Fragaria vesca 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Ipecacuanha 15x, Jequerity 15x, Juglans regia 15x, Lachesis mutus 15x, Ledum palustre 15x, Lycopodium clavatum 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Ova tosta 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharinum 15x, Saccharum lactis 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica urens 15x, Ustilago maidis 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Torula cerevisiae 16x.
OTC - PURPOSE SECTION
Formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2545-1 | Food Additives | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2545 | FOOD ADDITIVES (IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,) PELLET [NEWTON LABORATORIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20201201_9af2d6f4-baa8-5da9-e053-2995a90a3dac.zip |
Products#
Every source-derived product name is available through these pages.
- Food Additives
- Iris versicolor, Solidago virgaurea, Aconitum napellus, Agaricus muscarius, Allium cepa, Allium sativum, Antimonium crudum, Arsenicum album, Baptisia tinctoria, Bovista, Caffeinum, Capsicum annuum, Cinchona officinalis, Cinnamomum, Coccus cacti, Cynara scolymus, Fragaria vesca, Gelsemium sempervirens, Histaminum hydrochloricum, Ipecacuanha, Jequerity, Juglans regia, Lachesis mutus, Ledum palustre, Lycopodium clavatum, Mentha piperita, Natrum muriaticum, Nux moschata,
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BAPTISIA TINCTORIA ROOT
- LYCOPERDON UTRIFORME FRUITING BODY
- CAFFEINE
- CAPSICUM
- CINCHONA OFFICINALIS BARK
- CINNAMON
- PROTORTONIA CACTI
- CYNARA SCOLYMUS LEAF
- ALPINE STRAWBERRY
- GELSEMIUM SEMPERVIRENS ROOT
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- SOLIDAGO VIRGAUREA FLOWERING TOP
- URTICA URENS
- GINGER
- MENTHA PIPERITA
- ABRUS PRECATORIUS SEED
- JUGLANS REGIA LEAF
- USTILAGO MAYDIS
- LACHESIS MUTA VENOM
- NUTMEG
- PODOPHYLLUM
- SULFUR
- ASTACUS ASTACUS
- GLYCYRRHIZA GLABRA
- SOLANUM TUBEROSUM
- SACCHAROMYCES CEREVISIAE
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SEPIA OFFICINALIS JUICE
- SUCROSE CARAMEL
- SUCROSE
- EGG SHELL, COOKED
- LYCOPODIUM CLAVATUM SPORE
- RHODODENDRON TOMENTOSUM LEAFY TWIG
- ASCORBIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2545 | 55714-2545-1 |
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 |
|---|---|---|---|---|---|---|
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9af2d6f4-baa8-5da9-e053-2995a90a3dac | 2020-11-30 | Warnings | 55714-2545-1 55714-2545 55714254501 b5560b7f-8cdd-201f-e053-2995a90a50a3 9af2d6f4-baa8-5da9-e053-2995a90a3dac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.