Food Allergy - Additive by Newton Laboratories, Inc. Food 2444L

Food Allergy - Additive by

Drug Labeling and Warnings

Food Allergy - Additive by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOOD ALLERGY - ADDITIVE- iris vers., solidago, aconitum nap., agaricus musc., allium cepa, allium sat., antimon. crud., arsenicum alb., baptisia, bovista, caffeinum, capsicum, cinchona, cinnamomum, coccus, cynara, frageria, gelsemium, histaminum hydrochloricum, ipecac., jequirity, juglans reg., lachesis, ledum, lycopodium, mentha pip., nat. mur., nux mosch., ova tosta, phos., podoph. pelt., pulsatilla, rhus tox., saccharinum, sac. lac., sepia, sulphur, thiosinaminum, urtica ur., ustilago maidis, zingiber, anacard. occ., ascorbicum 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 2444L

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing, indigestion, vomiting, cramping and other related symptoms.

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

Active ingredients: Equal parts of Iris vers. 6x, Solidago 6x, Aconitum nap. 15x, Agaricus musc. 15x, Allium cepa 15x, Allium sat. 15x, Antimon. crud. 15x, Arsenicum alb. 15x, Baptisia 15x, Bovista 15x, Caffeinum 15x, Capsicum 15x, Cinchona 15x, Cinnamomum 15x, Coccus 15x, Cynara 15x, Frageria 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Jequirity 15x, Juglans reg. 15x, Lachesis 15x, Ledum 15x, Lycopodium 15x, Mentha pip. 15x, Nat. mur. 15x, Nux mosch. 15x, Ova tosta 15x, Phos. 15x, Podoph. pelt. 15x, Pulsatilla 15x, Rhus tox. 15x, Saccharinum 15x, Sac. lac. 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica ur. 15x, Ustilago maidis 15x., Zingiber 15x, Anacard. occ. 16x, Ascorbicum ac. 16x, Astacus 16x, Glycyrrhiza 16x, Lycopersicum 16x, Nat. nitricum 16x, Saccharum off. 16x, Sinapis nig. 16x, Solanum nig. 16x, Solanum tub. 16x, Torula cerevisiae 16x

OTC - PURPOSE SECTION

Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.

INACTIVE INGREDIENT SECTION

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

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

product label.

FOOD ALLERGY - ADDITIVE 
iris vers., solidago, aconitum nap., agaricus musc., allium cepa, allium sat., antimon. crud., arsenicum alb., baptisia, bovista, caffeinum, capsicum, cinchona, cinnamomum, coccus, cynara, frageria, gelsemium, histaminum hydrochloricum, ipecac., jequirity, juglans reg., lachesis, ledum, lycopodium, mentha pip., nat. mur., nux mosch., ova tosta, phos., podoph. pelt., pulsatilla, rhus tox., saccharinum, sac. lac., sepia, sulphur, thiosinaminum, urtica ur., ustilago maidis, zingiber, anacard. occ., ascorbicum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2444
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE16 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM16 [hp_X]  in 1 mL
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF16 [hp_X]  in 1 mL
ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY16 [hp_X]  in 1 mL
ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED16 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA16 [hp_X]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA16 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG16 [hp_X]  in 1 mL
LACTOSE (UNII: J2B2A4N98G) (ANHYDROUS LACTOSE - UNII:3SY5LH9PMK) LACTOSE16 [hp_X]  in 1 mL
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE16 [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
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA16 [hp_X]  in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS16 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER16 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE16 [hp_X]  in 1 mL
SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) (SOLANUM LYCOPERSICUM - UNII:0243Q4990L) SOLANUM LYCOPERSICUM16 [hp_X]  in 1 mL
SACCHARIN (UNII: FST467XS7D) (SACCHARIN - UNII:FST467XS7D) SACCHARIN16 [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
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [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
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 mL
AGARICUS BISPORUS WHOLE (UNII: B0FRQ940N7) (AGARICUS BISPORUS WHOLE - UNII:B0FRQ940N7) AGARICUS BISPORUS WHOLE15 [hp_X]  in 1 mL
SUCROSE PALMITATE (UNII: 3OSQ643ZK5) (SUCROSE PALMITATE - UNII:3OSQ643ZK5) SUCROSE PALMITATE16 [hp_X]  in 1 mL
ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE16 [hp_X]  in 1 mL
SINAPIS ALBA WHOLE (UNII: 66SFD3EC0P) (SINAPIS ALBA WHOLE - UNII:66SFD3EC0P) SINAPIS ALBA WHOLE16 [hp_X]  in 1 mL
ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3) (ALLIUM SATIVUM WHOLE - UNII:IIF21WT8O3) ALLIUM SATIVUM WHOLE15 [hp_X]  in 1 mL
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE15 [hp_X]  in 1 mL
ABRUS PRECATORIUS WHOLE (UNII: 0LE3OL7JFG) (ABRUS PRECATORIUS WHOLE - UNII:0LE3OL7JFG) ABRUS PRECATORIUS WHOLE15 [hp_X]  in 1 mL
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) (ZINGIBER OFFICINALE WHOLE - UNII:IN6Q3S3414) ZINGIBER OFFICINALE WHOLE15 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID16 [hp_X]  in 1 mL
ASTACUS CRAYFISH WHOLE (UNII: QKW8MJ4B42) (ASTACUS CRAYFISH WHOLE - UNII:QKW8MJ4B42) ASTACUS CRAYFISH WHOLE16 [hp_X]  in 1 mL
SODIUM NITRATE (UNII: 8M4L3H2ZVZ) (NITRATE ION - UNII:T93E9Y2844) SODIUM NITRATE16 [hp_X]  in 1 mL
CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON16 [hp_X]  in 1 mL
COCHINEAL (UNII: TZ8Z31B35M) (COCHINEAL - UNII:TZ8Z31B35M) COCHINEAL15 [hp_X]  in 1 mL
CYNARA SCOLYMUS WHOLE (UNII: 9N3437ZUU0) (CYNARA SCOLYMUS WHOLE - UNII:9N3437ZUU0) CYNARA SCOLYMUS WHOLE15 [hp_X]  in 1 mL
ANACARDIUM OCCIDENTALE WHOLE (UNII: 07P7GFE94P) (ANACARDIUM OCCIDENTALE WHOLE - UNII:07P7GFE94P) ANACARDIUM OCCIDENTALE WHOLE16 [hp_X]  in 1 mL
CALVATIA GIGANTEA WHOLE (UNII: BR6B7CG29T) (CALVATIA GIGANTEA WHOLE - UNII:BR6B7CG29T) CALVATIA GIGANTEA WHOLE15 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS15 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [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
FRAGARIA VESCA WHOLE (UNII: 5J340B7H82) (FRAGARIA VESCA WHOLE - UNII:5J340B7H82) FRAGARIA VESCA WHOLE15 [hp_X]  in 1 mL
JUGLANS REGIA WHOLE (UNII: 87EJ76IO83) (JUGLANS REGIA WHOLE - UNII:87EJ76IO83) JUGLANS REGIA WHOLE15 [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) ONION16 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC16 [hp_X]  in 1 mL
ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT16 [hp_X]  in 1 mL
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY16 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2444-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201912/31/2019
2NDC: 55714-2444-250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201912/31/2019
3NDC: 55714-2444-015 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201912/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/201912/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2444)

Revised: 12/2019
Document Id: 9aef851d-4296-ac36-e053-2995a90a6c0a
Set id: 8e7252ab-372c-df03-e053-2995a90a30d0
Version: 2
Effective Time: 20191230
 
Newton Laboratories, Inc.