FOOD ADDITIVES- iris versicolor, solidago virgaurea, aconitum napellus, agaricus muscarius, allium cepa, allium sativum, antimonium crudum, arsenicum album, baptisia tinctoria, bovista, caffeinum, capsicum annuum, cinchona officinalis, cinnamomum, coccus cacti, cynara scolymus, fragaria vesca, gelsemium sempervirens, histaminum hydrochloricum, ipecacuanha, jequerity, juglans regia, lachesis mutus, ledum palustre, lycopodium clavatum, mentha piperita, natrum muriaticum, nux moschata, liquid 
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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Food 2544L

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.

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 Iris versicolor 6x, Solidago virgaurea 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium cepa 15x, Allium sativum 15x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bovista 15x, Caffeinum 15x, Capsicum annuum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Coccus cacti 15x, Cynara scolymus 15x, Fragaria vesca 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Ipecacuanha 15x, Jequerity 15x, Juglans regia 15x, Lachesis mutus 15x, Ledum palustre 15x, Lycopodium clavatum 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Ova tosta 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharinum 15x, Saccharum lactis 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica urens 15x, Ustilago maidis 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

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

package label

FOOD ADDITIVES 
iris versicolor, solidago virgaurea, aconitum napellus, agaricus muscarius, allium cepa, allium sativum, antimonium crudum, arsenicum album, baptisia tinctoria, bovista, caffeinum, capsicum annuum, cinchona officinalis, cinnamomum, coccus cacti, cynara scolymus, fragaria vesca, gelsemium sempervirens, histaminum hydrochloricum, ipecacuanha, jequerity, juglans regia, lachesis mutus, ledum palustre, lycopodium clavatum, mentha piperita, natrum muriaticum, nux moschata, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2544
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EGG SHELL, COOKED (UNII: 24HBF856C8) (EGG SHELL, COOKED - UNII:24HBF856C8) EGG SHELL, COOKED15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG15 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID16 [hp_X]  in 1 mL
BLACK MUSTARD SEED (UNII: 8LTY55LQ8D) (BLACK MUSTARD SEED - UNII:8LTY55LQ8D) BLACK MUSTARD SEED16 [hp_X]  in 1 mL
SOLANUM NIGRUM WHOLE (UNII: 0FMD6WV47M) (SOLANUM NIGRUM WHOLE - UNII:0FMD6WV47M) SOLANUM NIGRUM WHOLE16 [hp_X]  in 1 mL
ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT16 [hp_X]  in 1 mL
SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) (SOLANUM LYCOPERSICUM - UNII:0243Q4990L) SOLANUM LYCOPERSICUM16 [hp_X]  in 1 mL
SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608) SODIUM NITRITE16 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA15 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY15 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION15 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
SACCHARIN (UNII: FST467XS7D) (SACCHARIN - UNII:FST467XS7D) SACCHARIN15 [hp_X]  in 1 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY TRISULFIDE15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT15 [hp_X]  in 1 mL
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY15 [hp_X]  in 1 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE15 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM15 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON15 [hp_X]  in 1 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI15 [hp_X]  in 1 mL
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF15 [hp_X]  in 1 mL
ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY15 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS15 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 mL
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE16 [hp_X]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA15 [hp_X]  in 1 mL
ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED15 [hp_X]  in 1 mL
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF15 [hp_X]  in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS15 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG15 [hp_X]  in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ) ASTACUS ASTACUS16 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA16 [hp_X]  in 1 mL
SOLANUM TUBEROSUM (UNII: 2A8I57T4MX) (SOLANUM TUBEROSUM - UNII:2A8I57T4MX) SOLANUM TUBEROSUM16 [hp_X]  in 1 mL
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE16 [hp_X]  in 1 mL
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) (ANHYDROUS LACTOSE - UNII:3SY5LH9PMK) LACTOSE, UNSPECIFIED FORM15 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2544-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2544)

Revised: 11/2020
Document Id: b5560b7f-8cdc-201f-e053-2995a90a50a3
Set id: 9aefc830-329c-5e35-e053-2a95a90a6ffe
Version: 2
Effective Time: 20201130
 
Newton Laboratories, Inc.