Allergies
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2024-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:26:16
Label at a glance#
ProductAllergies
Active ingredientULMUS RUBRA BARK, EGG SHELL, COOKED, SCHOENOCAULON OFFICINALE SEED, SAMBUCUS NIGRA FLOWERING TOP, SANGUINARIA CANADENSIS ROOT, LYCOPUS VIRGINICUS, LACTOSE, UNSPECIFIED FORM, CLAVICEPS PURPUREA SCLEROTIUM, TRILLIUM ERECTUM ROOT, ASCORBIC ACID, BLACK MUSTARD SEED, DATURA STRAMONIUM, TOBACCO LEAF, ALLYLTHIOUREA, URTICA URENS, ELYMUS REPENS ROOT, USTILAGO MAYDIS, WYETHIA HELENIOIDES ROOT, XEROPHYLLUM ASPHODELOIDES, APIS MELLIFERA, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AMANITA MUSCARIA FRUITING BODY, ALETRIS FARINOSA ROOT, ALFALFA, ONION, GARLIC, AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, ARTEMISIA VULGARIS ROOT, ARUNDO PLINIANA ROOT, AVENA SATIVA FLOWERING TOP, ATROPA BELLADONNA, BELLIS PERENNIS, LYCOPERDON UTRIFORME FRUITING BODY, BROMINE, BRYONIA ALBA ROOT, CAFFEINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALLUNA VULGARIS FLOWERING TOP, CAPSICUM, FELIS CATUS HAIR, MATRICARIA CHAMOMILLA, CHELIDONIUM MAJUS, DYSPHANIA AMBROSIOIDES, CINNAMON, HELIANTHEMUM CANADENSE, PROTORTONIA CACTI, CYNARA SCOLYMUS LEAF, CANIS LUPUS FAMILIARIS HAIR, DROSERA ANGLICA, SOLANUM DULCAMARA TOP, EUPHRASIA STRICTA, FAGOPYRUM ESCULENTUM, FAGUS SYLVATICA NUT, ALPINE STRAWBERRY, FRAXINUS AMERICANA BARK, GELSEMIUM SEMPERVIRENS ROOT, HISTAMINE DIHYDROCHLORIDE, HOUSE DUST, HYOSCYAMUS NIGER, ABRUS PRECATORIUS SEED, JUGLANS REGIA LEAF, POTASSIUM IODIDE, COW MILK, RHODODENDRON TOMENTOSUM LEAFY TWIG, LILIUM LANCIFOLIUM WHOLE FLOWERING, ONOSMODIUM VIRGINIANUM, PHYTOLACCA AMERICANA ROOT, YUCCA FILAMENTOSA, SACCHARIN, ECHINACEA, UNSPECIFIED, GOLDENSEAL, TOXICODENDRON PUBESCENS LEAF, SALIX NIGRA BARK, SULFUR, POPULUS BALSAMIFERA LEAF BUD, QUERCUS ROBUR NUT, MENTHA PIPERITA, NUTMEG, SOLANUM LYCOPERSICUM, ANACARDIUM OCCIDENTALE FRUIT, PTELEA TRIFOLIATA BARK, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, ROSA X DAMASCENA FLOWERING TOP, ASTACUS ASTACUS, GLYCYRRHIZA GLABRA, JUNIPERUS VIRGINIANA TWIG, SUCROSE, SODIUM NITRATE, SOLANUM NIGRUM WHOLE, SOLANUM TUBEROSUM, PARTHENIUM HYSTEROPHORUS, GINGER, SODIUM CHLORIDE, POPULUS TREMULOIDES LEAF, CORN SILK, SACCHAROMYCES CEREVISIAE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.
DOSAGE & ADMINISTRATION SECTION
Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up take 6 drops) as needed or 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, Taraxacum officinale 6x, Aconitum napellus 15x, Aethusa cynapium 15x, Agaricus muscarius 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Allium sativum 15x, Ambrosia artemisiaefolia 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Avena sativa 15x, Belladonna 15x, Bellis perrenis 15x, Bovista 15x, Bromium 15x, Bryonia 15x, Caffeinum 15x, Calcarea carbonica 15x, Calluna vulgaris, flos 15x, Capsicum annuum 15x, Cat hair 15x, Chamomilla 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cinnamomum 15x, Cistus canadensis 15x, Coccus cacti 15x, Cynara scolymus 15x, Dog hair 15x, Drosera 15x, Dulcamara 15x, Euphrasia officinalis 15x, Fagopyrum esculentum 15x, Fagus sylvatica 15x, Fragaria vesca 15x, Fraxinis americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, House dust 15x, Hyoscyamus niger 15x, Jequirity 15x, Juglans regia 15x, Kali iodatum 15x, Lac vaccinum 15x, Ledum palustre 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Onosmodium virginianum 15x, Ova tosta 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rhus toxicodendron 15x, Rosa damascena 15x, Sabadilla 15x, Saccharinum 15x, Saccharum lactis 15x, Salix nigra 15x, Sambucus nigra 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Stramonium 15x, Sulphur 15x, Tabacum 15x, Thiosinaminum 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Juniperus virginiana 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Parthenium 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x, Ulmus fulva 16x, Yucca filamentosa 16x.
OTC - PURPOSE SECTION
Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1519-1 | Allergies | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 4 | |
| 55714-1519-2 | Allergies | 50 mL in 1 BOTTLE, GLASS | LIQUID | 50 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1519 | ALLERGIES (APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM) LIQUID [NEWTON LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240308_9d4c4d88-43da-49dd-e053-2995a90af18d.zip |
Products#
Every source-derived product name is available through these pages.
- Allergies
- Apis mellifica, Echinacea, Hydrastis canadensis, Taraxacum officinale, Aconitum napellus, Aethusa cynapium, Agaricus muscarius, Aletris farinosa, Alfalfa, Allium cepa, Allium sativum, Ambrosia artemisiaefolia, Arsenicum album, Artemisia vulgaris, Arundo mauritanica, Avena sativa, Belladonna, Bellis perrenis, Bovista, Bromium, Bryonia, Caffeinum, Calcarea carbonica, Calluna vulgaris, flos, Capsicum annuum, Cat hair, Chamomilla, Chelidonium majus, Chenopodium anthelminticum, Cinnamomum
- ULMUS RUBRA BARK
- EGG SHELL, COOKED
- SCHOENOCAULON OFFICINALE SEED
- SAMBUCUS NIGRA FLOWERING TOP
- SANGUINARIA CANADENSIS ROOT
- LYCOPUS VIRGINICUS
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- CLAVICEPS PURPUREA SCLEROTIUM
- TRILLIUM ERECTUM ROOT
- ASCORBIC ACID
- BLACK MUSTARD SEED
- DATURA STRAMONIUM
- TOBACCO LEAF
- ALLYLTHIOUREA
- URTICA URENS
- ELYMUS REPENS ROOT
- USTILAGO MAYDIS
- WYETHIA HELENIOIDES ROOT
- XEROPHYLLUM ASPHODELOIDES
- WATER
- APIS MELLIFERA
- TARAXACUM OFFICINALE
- ACONITUM NAPELLUS
- AETHUSA CYNAPIUM
- ALCOHOL
- AMANITA MUSCARIA FRUITING BODY
- ALETRIS FARINOSA ROOT
- ALFALFA
- ONION
- GARLIC
- AMBROSIA ARTEMISIIFOLIA
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- ARTEMISIA VULGARIS ROOT
- ARUNDO PLINIANA ROOT
- AVENA SATIVA FLOWERING TOP
- ATROPA BELLADONNA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1519 | 55714-1519-2, 55714-1519-1 |
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 |
|---|---|---|---|---|---|---|
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 9d4c4d88-43da-49dd-e053-2995a90af18d | 2024-03-07 | Warnings | 55714-1519-1 55714-1519-2 55714-1519 55714151901 55714151902 13159f22-0245-4773-e063-6294a90a4510 9d4c4d88-43da-49dd-e053-2995a90af18d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.