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Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:46:32

Label at a glance#

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Active ingredientPOTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, POPULUS TREMULOIDES LEAF, ROSA X DAMASCENA FLOWERING TOP, SALIX NIGRA BARK, ELYMUS REPENS ROOT, DATURA STRAMONIUM, URTICA URENS, WYETHIA HELENIOIDES ROOT, QUERCUS ROBUR NUT, APIS MELLIFERA, GOLDENSEAL, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ONION, AMBROSIA ARTEMISIIFOLIA, AMMONIUM CARBONATE, ARALIA RACEMOSA ROOT, ARSENIC TRIOXIDE, ARTEMISIA VULGARIS ROOT, ARUNDO PLINIANA ROOT, BELLIS PERENNIS, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, CALLUNA VULGARIS FLOWERING TOP, CHELIDONIUM MAJUS, DYSPHANIA AMBROSIOIDES, HELIANTHEMUM CANADENSE, DROSERA ANGLICA, SOLANUM DULCAMARA TOP, ECHINACEA, UNSPECIFIED, FAGUS SYLVATICA NUT, FRAXINUS AMERICANA BARK, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, RHODODENDRON TOMENTOSUM LEAFY TWIG, LILIUM LANCIFOLIUM WHOLE FLOWERING, SODIUM CHLORIDE, POPULUS BALSAMIFERA LEAF BUD, ANEMONE PULSATILLA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, ONOSMODIUM VIRGINIANUM, SCHOENOCAULON OFFICINALE SEED, SANGUINARIA CANADENSIS ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ULMUS RUBRA BARK, HISTAMINE DIHYDROCHLORIDE, USTILAGO MAYDIS, PARTHENIUM HYSTEROPHORUS, XEROPHYLLUM ASPHODELOIDES, TRILLIUM ERECTUM ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms of late Summer and Fall pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

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

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Alfalfa 15x, Allium cepa 15x, Ambrosia artemisiaefolia 15x, Ammonium carbonicum 15x, Aralia racemosa 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cistus canadensis 15x, Drosera 15x, Dulcamara 15x, Eupatorium perfoliatum 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Ledum palustre 15x, Lillium tigrinum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Onosmodium virginianum 15x, Populus candicans 15x, Populus tremuloides 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Solidago virgaurea 15x, Stramonium 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Parthenium 16x, Ulmus fulva 16x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-245155714-2451-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 57 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b556d227-c5aa-0dd6-e053-2a95a90a95489bcda32f-2cc5-c581-e053-2995a90a163f2020-11-30WarningsExact identifier
spl set id: 9bcda32f-2cc5-c581-e053-2995a90a163f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.