Allergies
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2023-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:22:20
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: Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 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 mel 11x, Echinacea 11x, Hydrastis 11x, Taraxacum 11x, Aconitum nap 20x, Aethusa cynapium 20x, Agaricus musc 20x, Aletris 20x, Alfalfa 20x, Allium cepa 20x, Allium sat 20x, Ambrosia 20x, Arsenicum alb 20x, Artemisia 20x, Arundo ma 20x, Avena 20x, Belladonna 20x, Bellis 20x, Bovista 20x, Bromium 20x, Bryonia 20x, Caffeinum 20x, Calc carb 20x, Calluna vulgaris, flos 20x, Capsicum 20x, Cat hair 20x, Chamomilla 20x, Chelidonium maj 20x, Chenopodium anth 20x, Cinnamomum 20x, Cistus canadensis 20x, Coccus 20x, Cynara 20x, Dog hair 20x, Drosera 20x, Dulcamara 20x, Euphrasia 20x, Fagopyrum 20x, Fagus syl 20x, Fragaria 20x, Frax amer 20x, Gelsemium 20x, Histaminum hydro 20x, House dust 20x, Hyoscyamus 20x, Jequirity 20x, Juglans reg 20x, Kali iod 20x, Lac vac 20x, Ledum 20x, Lilium 20x, Lycopodium 20x, Lycopus 20x, Mentha pip 20x, Nat mur 20x, Nux mosch 20x, Onosmodium virginianum 20x, Ova tosta 20x, Phytolacca 20x, Populus can 20x, Populus trem 20x, Ptelea 20x, Pulsatilla 20x, Quercus gland sp 20x, Rhus tox 20x, Rosa dam 20x, Sabadilla 20x, Saccharinum 20x, Sac lac 20x, Salix nig 20x, Sambucus nig 20x, Sanguinaria 20x, Secale 20x, Stramonium 20x, Sulphur 20x, Tabacum 20x, Thiosinaminum 20x, Trillium 20x, Triticum 20x, Urtica ur 20x, Ustilago maidis 20x, Wyethia 20x, Xerophyllum 20x, Zingiber 20x, Anacardium occ 21x, Ascorbic ac 21x, Astacus 21x, Glycyrrhiza 21x, Juniperus virg 21x, Lycopersicum 21x, Nat nitricum 21x, Parthenium 21x, Saccharum off 21x, Sinapis nig 21x, Solanum nig 21x, Solanum tub 21x, Stigmata 21x, Torula cerevisiae 21x, Ulmus fulv 21x, Yucca 21x.
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 |
|---|---|---|---|---|---|---|
| 55714-4855-1 | Allergies | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4855 | 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.] | 1 | Current NDC, 1 package rows | 20230926_0631d5e5-9da4-bcb7-e063-6394a90a62de.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 |
|---|---|
| 55714-4855 | 55714-4855-1 |
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. | 0631d5e5-9da4-bcb7-e063-6394a90a62de | 2023-09-25 | Warnings | 55714-4855-1 55714-4855 55714485501 0631d415-6d36-2877-e063-6294a90a9c82 0631d5e5-9da4-bcb7-e063-6394a90a62de |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.