Food Allergy - Additive
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2019-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:47:34
Label at a glance#
ProductFood Allergy - Additive
Active ingredientCAFFEINE, CAPSICUM, CYNARA SCOLYMUS LEAF, ALPINE STRAWBERRY, ABRUS PRECATORIUS SEED, GLYCYRRHIZA GLABRA, MENTHA PIPERITA, NUTMEG, LACTOSE, SUCROSE, BLACK MUSTARD SEED, SOLANUM NIGRUM WHOLE, ALLYLTHIOUREA, USTILAGO MAYDIS, GINGER, HISTAMINE DIHYDROCHLORIDE, SOLANUM LYCOPERSICUM, SACCHARIN, SOLANUM TUBEROSUM, SACCHAROMYCES CEREVISIAE, ACONITUM NAPELLUS, ANTIMONY TRISULFIDE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, CINCHONA OFFICINALIS BARK, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, LACHESIS MUTA VENOM, LEDUM PALUSTRE TWIG, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PHOSPHORUS, PODOPHYLLUM, PULSATILLA VULGARIS, AGARICUS BISPORUS WHOLE, SUCROSE PALMITATE, ALLIUM CEPA WHOLE, SINAPIS ALBA WHOLE, ALLIUM SATIVUM WHOLE, CAPSICUM ANNUUM WHOLE, ABRUS PRECATORIUS WHOLE, ZINGIBER OFFICINALE WHOLE, ASCORBIC ACID, ASTACUS CRAYFISH WHOLE, SODIUM NITRATE, CINNAMON, COCHINEAL, CYNARA SCOLYMUS WHOLE, ANACARDIUM OCCIDENTALE WHOLE, CALVATIA GIGANTEA WHOLE, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, SULFUR, URTICA URENS, IRIS VERSICOLOR ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, FRAGARIA VESCA WHOLE, JUGLANS REGIA WHOLE, AMANITA MUSCARIA FRUITING BODY, ONION, GARLIC, ANACARDIUM OCCIDENTALE FRUIT, LYCOPERDON UTRIFORME FRUITING BODY
Label structure10 sections
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as itching, swelling, headaches, labored breathing, indigestion, vomiting, cramping and other related symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Active ingredients: Equal parts of Iris vers. 6x, Solidago 6x, Aconitum nap. 15x, Agaricus musc. 15x, Allium cepa 15x, Allium sat. 15x, Antimon. crud. 15x, Arsenicum alb. 15x, Baptisia 15x, Bovista 15x, Caffeinum 15x, Capsicum 15x, Cinchona 15x, Cinnamomum 15x, Coccus 15x, Cynara 15x, Frageria 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Jequirity 15x, Juglans reg. 15x, Lachesis 15x, Ledum 15x, Lycopodium 15x, Mentha pip. 15x, Nat. mur. 15x, Nux mosch. 15x, Ova tosta 15x, Phos. 15x, Podoph. pelt. 15x, Pulsatilla 15x, Rhus tox. 15x, Saccharinum 15x, Sac. lac. 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica ur. 15x, Ustilago maidis 15x., Zingiber 15x, Anacard. occ. 16x, Ascorbicum ac. 16x, Astacus 16x, Glycyrrhiza 16x, Lycopersicum 16x, Nat. nitricum 16x, Saccharum off. 16x, Sinapis nig. 16x, Solanum nig. 16x, Solanum tub. 16x, Torula cerevisiae 16x
OTC - PURPOSE SECTION
Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: 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
Products#
Every source-derived product name is available through these pages.
- Food Allergy - Additive
- Iris vers., Solidago, Aconitum nap., Agaricus musc., Allium cepa, Allium sat., Antimon. crud., Arsenicum alb., Baptisia, Bovista, Caffeinum, Capsicum, Cinchona, Cinnamomum, Coccus, Cynara, Frageria, Gelsemium, Histaminum hydrochloricum, Ipecac., Jequirity, Juglans reg., Lachesis, Ledum, Lycopodium, Mentha pip., Nat. mur., Nux mosch., Ova tosta, Phos., Podoph. pelt., Pulsatilla, Rhus tox., Saccharinum, Sac. lac., Sepia, Sulphur, Thiosinaminum, Urtica ur., Ustilago maidis, Zingiber, Anacard. occ., Ascorbicum
- CAFFEINE
- CAPSICUM
- CYNARA SCOLYMUS LEAF
- ALPINE STRAWBERRY
- ABRUS PRECATORIUS SEED
- GLYCYRRHIZA GLABRA
- MENTHA PIPERITA
- NUTMEG
- LACTOSE
- ANHYDROUS LACTOSE
- SUCROSE
- BLACK MUSTARD SEED
- SOLANUM NIGRUM WHOLE
- ALLYLTHIOUREA
- USTILAGO MAYDIS
- GINGER
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- SOLANUM LYCOPERSICUM
- SACCHARIN
- SOLANUM TUBEROSUM
- SACCHAROMYCES CEREVISIAE
- ACONITUM NAPELLUS
- ANTIMONY TRISULFIDE
- ANTIMONY CATION (3+)
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BAPTISIA TINCTORIA ROOT
- CINCHONA OFFICINALIS BARK
- GELSEMIUM SEMPERVIRENS ROOT
- IPECAC
- LACHESIS MUTA VENOM
- LEDUM PALUSTRE TWIG
- LYCOPODIUM CLAVATUM SPORE
- SODIUM CHLORIDE
- CHLORIDE ION
- PHOSPHORUS
- PODOPHYLLUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2444 | 55714-2444-1, 55714-2444-2, 55714-2444-0 |
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 |
|---|---|---|---|---|---|---|
| 9aef851d-4296-ac36-e053-2995a90a6c0a | 8e7252ab-372c-df03-e053-2995a90a30d0 | 2019-12-30 | Warnings | 9aef851d-4296-ac36-e053-2995a90a6c0a 8e7252ab-372c-df03-e053-2995a90a30d0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.