Hay 2213P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

HAY FEVER- zerophyllum asphodeloides, alfalfa, avena sativa pollen, cynosurus cristatus pollen, echinochloa crus-galli pollen, poa pratensis pollen, anthoxanthum odoratum pollen, agrostis gigantea pollen, bromus secalinus pollen, alopecurus pratensis pollen, phleum pratense pollen, festuca pratensis pollen, holcus lanatus pollen, lolium perenne pollen, fagus sylvatica pollen, betula pendula pollen, quercus alba pollen, fraxinus excelsior pollen, corylus americana pollen, populus nigra pollen 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.

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Hay 2213P-Dis

INDICATIONS & USAGE SECTION

Hay Fever  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 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Xerophyllum 30x, Alfalfa 15x, Allersodes 15x, Allium cepa 15x, Ambrosia 15x, Ammon. carb. 15x, Aralia rac. 15x, Arsenicum alb. 15x, Artemisia 15x, Bellis 15x, Berber. vulg. 15x, Bryonia 15x , Chelidonium maj. 15x, Eupatorium perf. 15x, Euphrasia 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Nat.mur. 15x, Sabadilla 15x, Solidago 15x, Trillium 15x, Ustilago maidis 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

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

package label

HAY FEVER 
zerophyllum asphodeloides, alfalfa, avena sativa pollen, cynosurus cristatus pollen, echinochloa crus-galli pollen, poa pratensis pollen, anthoxanthum odoratum pollen, agrostis gigantea pollen, bromus secalinus pollen, alopecurus pratensis pollen, phleum pratense pollen, festuca pratensis pollen, holcus lanatus pollen, lolium perenne pollen, fagus sylvatica pollen, betula pendula pollen, quercus alba pollen, fraxinus excelsior pollen, corylus americana pollen, populus nigra pollen pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
XEROPHYLLUM ASPHODELOIDES (UNII: 9I4XB1GP2B) (XEROPHYLLUM ASPHODELOIDES - UNII:9I4XB1GP2B) XEROPHYLLUM ASPHODELOIDES30 [hp_X]  in 1 g
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA15 [hp_X]  in 1 g
AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7) AVENA SATIVA POLLEN15 [hp_X]  in 1 g
CYNOSURUS CRISTATUS POLLEN (UNII: SES68PF95U) (CYNOSURUS CRISTATUS POLLEN - UNII:SES68PF95U) CYNOSURUS CRISTATUS POLLEN15 [hp_X]  in 1 g
ECHINOCHLOA CRUS-GALLI POLLEN (UNII: 6941ZR795V) (ECHINOCHLOA CRUS-GALLI POLLEN - UNII:6941ZR795V) ECHINOCHLOA CRUS-GALLI POLLEN15 [hp_X]  in 1 g
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN15 [hp_X]  in 1 g
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN15 [hp_X]  in 1 g
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN15 [hp_X]  in 1 g
BROMUS SECALINUS POLLEN (UNII: Q4T1SJ3046) (BROMUS SECALINUS POLLEN - UNII:Q4T1SJ3046) BROMUS SECALINUS POLLEN15 [hp_X]  in 1 g
ALOPECURUS PRATENSIS POLLEN (UNII: DG1ZL6W96V) (ALOPECURUS PRATENSIS POLLEN - UNII:DG1ZL6W96V) ALOPECURUS PRATENSIS POLLEN15 [hp_X]  in 1 g
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN15 [hp_X]  in 1 g
FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (FESTUCA PRATENSIS POLLEN - UNII:A0WFQ8P6N1) FESTUCA PRATENSIS POLLEN15 [hp_X]  in 1 g
HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN15 [hp_X]  in 1 g
LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN15 [hp_X]  in 1 g
FAGUS SYLVATICA POLLEN (UNII: 63218N1ZBI) (FAGUS SYLVATICA POLLEN - UNII:63218N1ZBI) FAGUS SYLVATICA POLLEN15 [hp_X]  in 1 g
BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN15 [hp_X]  in 1 g
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN15 [hp_X]  in 1 g
FRAXINUS EXCELSIOR POLLEN (UNII: 1824QUA0U3) (FRAXINUS EXCELSIOR POLLEN - UNII:1824QUA0U3) FRAXINUS EXCELSIOR POLLEN15 [hp_X]  in 1 g
CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN15 [hp_X]  in 1 g
POPULUS NIGRA POLLEN (UNII: 0MGE63QPFJ) (POPULUS NIGRA POLLEN - UNII:0MGE63QPFJ) POPULUS NIGRA POLLEN15 [hp_X]  in 1 g
PLATANUS ORIENTALIS POLLEN (UNII: Y1A4835L6K) (PLATANUS ORIENTALIS POLLEN - UNII:Y1A4835L6K) PLATANUS ORIENTALIS POLLEN15 [hp_X]  in 1 g
ULMUS GLABRA POLLEN (UNII: T2K08L297Q) (ULMUS GLABRA POLLEN - UNII:T2K08L297Q) ULMUS GLABRA POLLEN15 [hp_X]  in 1 g
SALIX ALBA POLLEN (UNII: WQ580684IZ) (SALIX ALBA POLLEN - UNII:WQ580684IZ) SALIX ALBA POLLEN15 [hp_X]  in 1 g
NARCISSUS PSEUDONARCISSUS (UNII: Q2D0SKW2P4) (NARCISSUS PSEUDONARCISSUS - UNII:Q2D0SKW2P4) NARCISSUS PSEUDONARCISSUS15 [hp_X]  in 1 g
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA FLOWER15 [hp_X]  in 1 g
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ) (LILIUM CANDIDUM FLOWER - UNII:COV655U2CJ) LILIUM CANDIDUM FLOWER15 [hp_X]  in 1 g
PRIMULA VULGARIS (UNII: KZ3PRK2V0J) (PRIMULA VULGARIS - UNII:KZ3PRK2V0J) PRIMULA VULGARIS15 [hp_X]  in 1 g
DIANTHUS CARYOPHYLLUS FLOWER (UNII: B0D836E90S) (DIANTHUS CARYOPHYLLUS FLOWER - UNII:B0D836E90S) DIANTHUS CARYOPHYLLUS FLOWER15 [hp_X]  in 1 g
ULEX EUROPAEUS FLOWER (UNII: 398DBS1PXN) (ULEX EUROPAEUS FLOWER - UNII:398DBS1PXN) ULEX EUROPAEUS FLOWER15 [hp_X]  in 1 g
CYTISUS SCOPARIUS POLLEN (UNII: I0NS0040GH) (CYTISUS SCOPARIUS POLLEN - UNII:I0NS0040GH) CYTISUS SCOPARIUS POLLEN15 [hp_X]  in 1 g
CALLUNA VULGARIS POLLEN (UNII: 5Q1IE9V5YZ) (CALLUNA VULGARIS POLLEN - UNII:5Q1IE9V5YZ) CALLUNA VULGARIS POLLEN15 [hp_X]  in 1 g
CRATAEGUS MONOGYNA POLLEN (UNII: X6049S3TX1) (CRATAEGUS MONOGYNA POLLEN - UNII:X6049S3TX1) CRATAEGUS MONOGYNA POLLEN15 [hp_X]  in 1 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 g
ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT15 [hp_X]  in 1 g
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES15 [hp_X]  in 1 g
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE15 [hp_X]  in 1 g
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA15 [hp_X]  in 1 g
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP15 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 1 g
ONOSMODIUM VIRGINIANUM WHOLE (UNII: 604NK4250S) (ONOSMODIUM VIRGINIANUM WHOLE - UNII:604NK4250S) ONOSMODIUM VIRGINIANUM WHOLE15 [hp_X]  in 1 g
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF15 [hp_X]  in 1 g
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 g
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT15 [hp_X]  in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM15 [hp_X]  in 1 g
ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT15 [hp_X]  in 1 g
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS15 [hp_X]  in 1 g
WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N) WYETHIA HELENIOIDES ROOT15 [hp_X]  in 1 g
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION15 [hp_X]  in 1 g
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA15 [hp_X]  in 1 g
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (CARBONATE ION - UNII:7UJQ5OPE7D) CARBONATE ION15 [hp_X]  in 1 g
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT15 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)15 [hp_X]  in 1 g
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S) ARTEMISIA VULGARIS ROOT15 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS15 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS15 [hp_X]  in 1 g
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]  in 1 g
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA15 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE15 [hp_X]  in 1 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 g
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE15 [hp_X]  in 1 g
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION15 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE15 [hp_X]  in 1 g
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED15 [hp_X]  in 1 g
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP15 [hp_X]  in 1 g
TRILLIUM ERECTUM ROOT (UNII: AHW6F0T2X0) (TRILLIUM ERECTUM ROOT - UNII:AHW6F0T2X0) TRILLIUM ERECTUM ROOT15 [hp_X]  in 1 g
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS15 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA3 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2213-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2213-257 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2213-07 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2213)

Revised: 10/2019
Document Id: 95ff354d-37a5-ea16-e053-2995a90aec0d
Set id: 9790c282-180c-b7e3-f4bc-d7d7dcdd15fd
Version: 3
Effective Time: 20191028