POLLEN-WEEDS- ginkgo biloba, hydrastis canadensis, taraxacum officinale, adrenalinum , aletris farinosa, alfalfa, allium cepa, antimonium tartaricum, arsenicum album, artemisia vulgaris, baptisia tinctoria, bellis perennis, berberis vulgaris, bryonia, calluna vulgaris, flos, chelidonium majus, chenopodium anthelminticum, dioscorea vilosa, euphrasia officinalis, fagus sylvatica, fraxinus americana, gelsemium sempervirens, histaminum hydrochloricum, kali bichromicum, kali iodatum, lachesis mutus, lilium tigrinum, pellet Newton Laboratories, Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ------Pollen 2500P
INDICATIONS & USAGE SECTION Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.
DOSAGE & ADMINISTRATION SECTION
OTC - ACTIVE INGREDIENT SECTION Equal parts of Ginkgo biloba 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Adrenalinum 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Antimonium tartaricum 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Baptisia tinctoria 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Dioscorea vilosa 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sambucus nigra 15x, Thyroidinum 15x, Trifolium pratense 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Juniperus virginiana 16x, Parthenium 16x, Ulmus fulva 16x, Yucca filamentosa 16x.
OTC - PURPOSE SECTION Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.
INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, organie 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 no 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
POLLEN-WEEDS ginkgo biloba, hydrastis canadensis, taraxacum officinale, adrenalinum , aletris farinosa, alfalfa, allium cepa, antimonium tartaricum, arsenicum album, artemisia vulgaris, baptisia tinctoria, bellis perennis, berberis vulgaris, bryonia, calluna vulgaris, flos, chelidonium majus, chenopodium anthelminticum, dioscorea vilosa, euphrasia officinalis, fagus sylvatica, fraxinus americana, gelsemium sempervirens, histaminum hydrochloricum, kali bichromicum, kali iodatum, lachesis mutus, lilium tigrinum, pellet
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:55714-250 0 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PARTHENIUM HYSTERO PHO RUS (UNII: 151F45R21P) (PARTHENIUM HYSTEROPHORUS PARTHENIUM 16 [hp_X] - UNII:151F45R21P) HYSTEROPHORUS in 1 g XERO PHYLLUM ASPHO DELO IDES (UNII: 9 I4XB1GP2B) (XEROPHYLLUM XEROPHYLLUM 15 [hp_X] ASPHODELOIDES - UNII:9 I4XB1GP2B) ASPHODELOIDES in 1 g 15 [hp_X] EPINEPHRINE (UNII: YKH8 34O4BH) (EPINEPHRINE - UNII:YKH8 34O4BH) EPINEPHRINE in 1 g 15 [hp_X] ALFALFA (UNII: DJO9 34BRBD) (ALFALFA - UNII:DJO9 34BRBD) ALFALFA in 1 g ALETRIS FARINO SA RO O T (UNII: O0 21JGR9 7X) (ALETRIS FARINOSA ROOT - 15 [hp_X] ALETRIS FARINOSA ROOT UNII:O0 21JGR9 7X) in 1 g ARTEMISIA VULGARIS RO O T (UNII: 32MP8 23R8 S) (ARTEMISIA VULGARIS ROOT - ARTEMISIA VULGARIS 15 [hp_X] UNII:32MP8 23R8 S) ROOT in 1 g 15 [hp_X] BELLIS PERENNIS (UNII: 2HU33I0 3UY) (BELLIS PERENNIS - UNII:2HU33I0 3UY) BELLIS PERENNIS in 1 g DYSPHANIA AMBRO SIO IDES (UNII: 4H5RSU0 8 7I) (DYSPHANIA AMBROSIOIDES - 15 [hp_X] DYSPHANIA AMBROSIOIDES UNII:4H5RSU0 8 7I) in 1 g LYCO PUS VIRGINICUS (UNII: TWH5125Q6 F) (LYCOPUS VIRGINICUS - 15 [hp_X] LYCOPUS VIRGINICUS UNII:TWH5125Q6 F) in 1 g PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA PHYTOLACCA AMERICANA 15 [hp_X] ROOT - UNII:11E6 VI8 VEG) ROOT in 1 g PO PULUS BALSAMIFERA LEAF BUD (UNII: 9 CQ6 C0 0 G3C) (POPULUS BALSAMIFERA POPULUS BALSAMIFERA 15 [hp_X] LEAF BUD - UNII:9 CQ6 C0 0 G3C) LEAF BUD in 1 g PO PULUS TREMULO IDES LEAF (UNII: 7IIH57D9 E0 ) (POPULUS TREMULOIDES LEAF - POPULUS TREMULOIDES 15 [hp_X] UNII:7IIH57D9 E0 ) LEAF in 1 g PTELEA TRIFO LIATA BARK (UNII: 5KQR6 FTT0 D) (PTELEA TRIFOLIATA BARK - 15 [hp_X] PTELEA TRIFOLIATA BARK UNII:5KQR6 FTT0 D) in 1 g SAMBUCUS NIGRA FLO WERING TO P (UNII: CT0 3BSA18 U) (SAMBUCUS NIGRA SAMBUCUS NIGRA 15 [hp_X] FLOWERING TOP - UNII:CT0 3BSA18 U) FLOWERING TOP in 1 g TRILLIUM ERECTUM RO O T (UNII: AHW6 F0 T2X0 ) (TRILLIUM ERECTUM ROOT - 15 [hp_X] TRILLIUM ERECTUM ROOT UNII:AHW6 F0 T2X0 ) in 1 g ELYMUS REPENS RO O T (UNII: 3IXW0 F6 P8 W) (ELYMUS REPENS ROOT - 15 [hp_X] ELYMUS REPENS ROOT UNII:3IXW0 F6 P8 W) in 1 g 15 [hp_X] URTICA URENS (UNII: IHN2NQ5OF9 ) (URTICA URENS - UNII:IHN2NQ5OF9 ) URTICA URENS in 1 g WYETHIA HELENIO IDES RO O T (UNII: J10 PD1AQ0 N) (WYETHIA HELENIOIDES ROOT - WYETHIA HELENIOIDES 15 [hp_X] UNII:J10 PD1AQ0 N) ROOT in 1 g YUCCA FILAMENTO SA (UNII: T6 VR38 UJ9 I) (YUCCA FILAMENTOSA - 16 [hp_X] YUCCA FILAMENTOSA UNII:T6 VR38 UJ9 I) in 1 g HISTAMINE DIHYDRO CHLO RIDE (UNII: 3POA0 Q6 44U) (HISTAMINE - HISTAMINE 15 [hp_X] UNII:8 20 48 4N8 I3) DIHYDROCHLORIDE in 1 g JUNIPERUS VIRGINIANA TWIG (UNII: 532BCG0 8 0 L) (JUNIPERUS VIRGINIANA TWIG - JUNIPERUS VIRGINIANA 16 [hp_X] UNII:532BCG0 8 0 L) TWIG in 1 g THYRO ID, UNSPECIFIED (UNII: 0 B4FDL9 I6 P) (THYROID, UNSPECIFIED - 15 [hp_X] THYROID, UNSPECIFIED UNII:0 B4FDL9 I6 P) in 1 g 15 [hp_X] USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS in 1 g 15 [hp_X] O NIO N (UNII: 49 2225Q21H) (ONION - UNII:49 2225Q21H) ONION in 1 g ANTIMO NY PO TASSIUM TARTRATE (UNII: DL6 OZ476 V3) (ANTIMONY CATION (3+) - ANTIMONY POTASSIUM 15 [hp_X] UNII:0 6 9 6 47RPT5) TARTRATE in 1 g 15 [hp_X] ARSENIC TRIO XIDE (UNII: S7V9 2P6 7HO) (ARSENIC CATION (3+) - UNII:C9 6 6 13F5AV) ARSENIC TRIOXIDE in 1 g BAPTISIA TINCTO RIA RO O T (UNII: 5EF0 HWI5WU) (BAPTISIA TINCTORIA ROOT - 15 [hp_X] BAPTISIA TINCTORIA ROOT UNII:5EF0 HWI5WU) in 1 g BERBERIS VULGARIS RO O T BARK (UNII: 1TH8 Q20 J0 U) (BERBERIS VULGARIS ROOT BERBERIS VULGARIS ROOT 15 [hp_X] BARK - UNII:1TH8 Q20 J0 U) BARK in 1 g 15 [hp_X] BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT - UNII:T7J0 46 YI2B) BRYONIA ALBA ROOT in 1 g CHELIDO NIUM MAJUS (UNII: 7E8 8 9 U5RNN) (CHELIDONIUM MAJUS - 15 [hp_X] CHELIDONIUM MAJUS UNII:7E8 8 9 U5RNN) in 1 g 15 [hp_X] EUPHRASIA STRICTA (UNII: C9 6 42I9 1WL) (EUPHRASIA STRICTA - UNII:C9 6 42I9 1WL) EUPHRASIA STRICTA in 1 g GELSEMIUM SEMPERVIRENS RO O T (UNII: 6 39 KR6 0 Q1Q) (GELSEMIUM GELSEMIUM SEMPERVIRENS 15 [hp_X] SEMPERVIRENS ROOT - UNII:6 39 KR6 0 Q1Q) ROOT in 1 g PO TASSIUM DICHRO MATE (UNII: T4423S18 FM) (DICHROMATE ION - 15 [hp_X] POTASSIUM DICHROMATE UNII:9 LKY4BFN2V) in 1 g 15 [hp_X] PO TASSIUM IO DIDE (UNII: 1C4QK22F9 J) (IODIDE ION - UNII:0 9 G4I6 V8 6 Q) POTASSIUM IODIDE in 1 g LACHESIS MUTA VENO M (UNII: VSW71SS0 7I) (LACHESIS MUTA VENOM - 15 [hp_X] LACHESIS MUTA VENOM UNII:VSW71SS0 7I) in 1 g LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM CLAVATUM LYCOPODIUM CLAVATUM 15 [hp_X] SPORE - UNII:C8 8 X29 Y479 ) SPORE in 1 g ANEMO NE PULSATILLA (UNII: I76 KB35JEV) (ANEMONE PULSATILLA - 15 [hp_X] ANEMONE PULSATILLA UNII:I76 KB35JEV) in 1 g SCHO ENO CAULO N O FFICINALE SEED (UNII: 6 NAF16 8 9 IO) (SCHOENOCAULON SCHOENOCAULON 15 [hp_X] OFFICINALE SEED - UNII:6 NAF16 8 9 IO) OFFICINALE SEED in 1 g DIO SCO REA VILLO SA TUBER (UNII: IWY3IWX2G8 ) (DIOSCOREA VILLOSA TUBER - DIOSCOREA VILLOSA 15 [hp_X] UNII:IWY3IWX2G8 ) TUBER in 1 g 6 [hp_X] GINKGO (UNII: 19 FUJ2C58 T) (GINKGO - UNII:19 FUJ2C58 T) GINKGO in 1 g TARAXACUM O FFICINALE (UNII: 39 9 8 1FM375) (TARAXACUM OFFICINALE - 6 [hp_X] TARAXACUM OFFICINALE UNII:39 9 8 1FM375) in 1 g 6 [hp_X] GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV) GOLDENSEAL in 1 g Q UERCUS RO BUR NUT (UNII: Q7MU1F4GLY) (QUERCUS ROBUR NUT - 15 [hp_X] QUERCUS ROBUR NUT UNII:Q7MU1F4GLY) in 1 g CALLUNA VULGARIS FLO WERING TO P (UNII: D9 PC510 CQV) (CALLUNA VULGARIS CALLUNA VULGARIS 15 [hp_X] FLOWERING TOP - UNII:D9 PC510 CQV) FLOWERING TOP in 1 g ULMUS RUBRA BARK (UNII: 9 1QY4PXU8 Q) (ULMUS RUBRA BARK - 16 [hp_X] ULMUS RUBRA BARK UNII:9 1QY4PXU8 Q) in 1 g FAGUS SYLVATICA NUT (UNII: I57ERU26 0 1) (FAGUS SYLVATICA NUT - 15 [hp_X] FAGUS SYLVATICA NUT UNII:I57ERU26 0 1) in 1 g FRAXINUS AMERICANA BARK (UNII: 0 B24UR1O1S) (FRAXINUS AMERICANA BARK - FRAXINUS AMERICANA 15 [hp_X] UNII:0 B24UR1O1S) BARK in 1 g LILIUM LANCIFO LIUM WHO LE FLO WERING (UNII: X6 7Z29 6 3PI) (LILIUM LILIUM LANCIFOLIUM 15 [hp_X] LANCIFOLIUM WHOLE FLOWERING - UNII:X6 7Z29 6 3PI) WHOLE FLOWERING in 1 g RO SA DAMASCENA FLO WERING TO P (UNII: 21W8 2Q76 4G) (ROSA DAMASCENA ROSA DAMASCENA 15 [hp_X] FLOWERING TOP - UNII:21W8 2Q76 4G) FLOWERING TOP in 1 g TRIFO LIUM PRATENSE FLO WER (UNII: 4JS0 8 38 8 28 ) (TRIFOLIUM PRATENSE TRIFOLIUM PRATENSE 15 [hp_X] FLOWER - UNII:4JS0 8 38 8 28 ) FLOWER in 1 g 15 [hp_X] SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK in 1 g
Inactive Ingredients Ingredient Name Strength SUCRO SE (UNII: C151H8 M554)
Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:55714-250 0 - 28 g in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n 1 0 1/0 1/20 19 1 Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date unappro ved ho meo pathic 0 1/0 1/20 19
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment Name Addre ss ID/FEI Busine ss Ope rations Newto n Labo rato ries, Inc. 78 8 79 36 10 manufacture(55714-250 0 )
Revised: 1/2020 Newton Laboratories, Inc.