Label: FOOD ALLERGY - ADDITIVE- e102 tartrazine, e104 quinoline yellow, e110 sunset/orange yellow, e122 carmoisine, e123 armaranth, e124 cochineal red a, e127 erythrosine, d128 red 2g, e 132 indigotine, e141 copper/chlorophyll complex, e142 green s, e211 sodium benzoate, e212 potassium benzoate, e216 propyl p-hydroxybenzoate, e223 sodium metabisulphate, e231 orthophenylphenol, e250 sodium nitrate, e300 ascorbic acid, e399 sodium mono/bi/triphosphate, e951 aspartame, monosodium glutamate, beef, pork, lamb, chicken, turkey, clam pellet

  • NDC Code(s): 55714-2315-0, 55714-2315-1, 55714-2315-2
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated March 1, 2011

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

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

  • 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

    Allersodes 60x, Allersodes 15x,Histaminum hydrochloricum 15x, Lycopersicum 15x, Saccharinum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Aconitum nap. 10x, Antimon.crud. 10x, Arsenicum alb. 10x, Baptisia 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Ledum 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Sulphur 10x, Urtica ur. 10x, Iris vers. 3x, Solidago 3x.

  • OTC - PURPOSE SECTION

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

  • 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

  • INGREDIENTS AND APPEARANCE
    FOOD ALLERGY - ADDITIVE  
    e102 tartrazine, e104 quinoline yellow, e110 sunset/orange yellow, e122 carmoisine, e123 armaranth, e124 cochineal red a, e127 erythrosine, d128 red 2g, e 132 indigotine, e141 copper/chlorophyll complex, e142 green s, e211 sodium benzoate, e212 potassium benzoate, e216 propyl p-hydroxybenzoate, e223 sodium metabisulphate, e231 orthophenylphenol, e250 sodium nitrate, e300 ascorbic acid, e399 sodium mono/bi/triphosphate, e951 aspartame, monosodium glutamate, beef, pork, lamb, chicken, turkey, clam pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Egg (UNII: 291P45F896) (Egg - UNII:291P45F896) Egg60 [hp_X]  in 1 g
    Fd&c Yellow No. 5 (UNII: I753WB2F1M) (Fd&c Yellow No. 5 - UNII:I753WB2F1M) Fd&c Yellow No. 560 [hp_X]  in 1 g
    D&c Yellow No. 10 (UNII: 35SW5USQ3G) (D&c Yellow No. 10 - UNII:35SW5USQ3G) D&c Yellow No. 1060 [hp_X]  in 1 g
    Fd&c Yellow No. 6 (UNII: H77VEI93A8) (Food Yellow 3 Free Acid - UNII:G2B7JWK1GG) Fd&c Yellow No. 660 [hp_X]  in 1 g
    Carmoisine (UNII: DR4641L47F) (Carmoisine - UNII:DR4641L47F) Carmoisine60 [hp_X]  in 1 g
    Amaranth (UNII: 37RBV3X49K) (Amaranth Acid - UNII:02J7X17ZUQ) Amaranth60 [hp_X]  in 1 g
    Ponceau 4r (UNII: Z525CBK9PG) (Ponceau 4r - UNII:Z525CBK9PG) Ponceau 4r60 [hp_X]  in 1 g
    Fd&c Red No. 3 (UNII: PN2ZH5LOQY) (Tetraiodofluorescein - UNII:1A878FZQ9B) Fd&c Red No. 360 [hp_X]  in 1 g
    Acid Red 1 (UNII: 3365R6427R) (Acid Red 1 - UNII:3365R6427R) Acid Red 160 [hp_X]  in 1 g
    Fd&c Blue No. 2 (UNII: L06K8R7DQK) (Fd&c Blue No. 2 - UNII:L06K8R7DQK) Fd&c Blue No. 260 [hp_X]  in 1 g
    Sodium Copper Chlorophyllin (UNII: 1D276TYV9O) (Sodium - UNII:9NEZ333N27) Sodium Copper Chlorophyllin60 [hp_X]  in 1 g
    Acid Green 50 (UNII: 9B7E8Y9D0X) (Acid Green 50 - UNII:9B7E8Y9D0X) Acid Green 5060 [hp_X]  in 1 g
    Sodium Benzoate (UNII: OJ245FE5EU) (Benzoic Acid - UNII:8SKN0B0MIM) Sodium Benzoate60 [hp_X]  in 1 g
    Potassium Benzoate (UNII: 763YQN2K7K) (Potassium - UNII:RWP5GA015D) Potassium Benzoate60 [hp_X]  in 1 g
    Propylparaben (UNII: Z8IX2SC1OH) (Propylparaben - UNII:Z8IX2SC1OH) Propylparaben60 [hp_X]  in 1 g
    Sodium Dithionate (UNII: RPF7Z41GAW) (Sodium - UNII:9NEZ333N27) Sodium Dithionate60 [hp_X]  in 1 g
    2-phenylphenol (UNII: D343Z75HT8) (2-phenylphenol - UNII:D343Z75HT8) 2-phenylphenol60 [hp_X]  in 1 g
    Sodium Nitrite (UNII: M0KG633D4F) (Nitrite Ion - UNII:J39976L608) Sodium Nitrite60 [hp_X]  in 1 g
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 [hp_X]  in 1 g
    Sodium Tripolyphosphate (UNII: 5HK03SA80J) (Tripolyphosphate Ion - UNII:5798IYA5AY) Sodium Tripolyphosphate60 [hp_X]  in 1 g
    Aspartame (UNII: Z0H242BBR1) (Aspartame - UNII:Z0H242BBR1) Aspartame60 [hp_X]  in 1 g
    Monosodium Glutamate (UNII: W81N5U6R6U) (Glutamic Acid - UNII:3KX376GY7L) Monosodium Glutamate60 [hp_X]  in 1 g
    Beef (UNII: 4PIB2155QP) (Beef - UNII:4PIB2155QP) Beef60 [hp_X]  in 1 g
    Pork (UNII: O138UB266J) (Pork - UNII:O138UB266J) Pork60 [hp_X]  in 1 g
    Lamb (UNII: FOF26T73HA) (Lamb - UNII:FOF26T73HA) Lamb60 [hp_X]  in 1 g
    Chicken (UNII: 0X8Q245Y7B) (Chicken - UNII:0X8Q245Y7B) Chicken60 [hp_X]  in 1 g
    Turkey (UNII: 8E9NT44R8I) (Turkey - UNII:8E9NT44R8I) Turkey60 [hp_X]  in 1 g
    Quahog, Unspecified (UNII: 226LY0AFR9) (Quahog, Unspecified - UNII:226LY0AFR9) Quahog, Unspecified60 [hp_X]  in 1 g
    Crab Leg, Unspecified (UNII: S1VF61QLO9) (Crab Leg, Unspecified - UNII:S1VF61QLO9) Crab Leg, Unspecified60 [hp_X]  in 1 g
    Oyster, Unspecified (UNII: S614XWR17V) (Oyster, Unspecified - UNII:S614XWR17V) Oyster, Unspecified60 [hp_X]  in 1 g
    Shrimp, Unspecified (UNII: 1891LE191T) (Shrimp, Unspecified - UNII:1891LE191T) Shrimp, Unspecified60 [hp_X]  in 1 g
    Scallop, Unspecified (UNII: D380C73WOU) (Scallop, Unspecified - UNII:D380C73WOU) Scallop, Unspecified60 [hp_X]  in 1 g
    Amanita Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Fruiting Body - UNII:DIF093I037) Amanita Muscaria Fruiting Body15 [hp_X]  in 1 g
    Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion15 [hp_X]  in 1 g
    Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic15 [hp_X]  in 1 g
    Anacardium Occidentale Fruit (UNII: 4A10JR4E7E) (Anacardium Occidentale Fruit - UNII:4A10JR4E7E) Anacardium Occidentale Fruit15 [hp_X]  in 1 g
    Lycoperdon Utriforme Fruiting Body (UNII: K2A74U428F) (Lycoperdon Utriforme Fruiting Body - UNII:K2A74U428F) Lycoperdon Utriforme Fruiting Body15 [hp_X]  in 1 g
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine15 [hp_X]  in 1 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 g
    Cinnamon (UNII: 5S29HWU6QB) (Cinnamon - UNII:5S29HWU6QB) Cinnamon15 [hp_X]  in 1 g
    Cynara Scolymus Leaf (UNII: B71UA545DE) (Cynara Scolymus Leaf - UNII:B71UA545DE) Cynara Scolymus Leaf15 [hp_X]  in 1 g
    Alpine Strawberry (UNII: CG6IX3GCMU) (Alpine Strawberry - UNII:CG6IX3GCMU) Alpine Strawberry15 [hp_X]  in 1 g
    Abrus Precatorius Seed (UNII: 3OM8I6L7CD) (Abrus Precatorius Seed - UNII:3OM8I6L7CD) Abrus Precatorius Seed15 [hp_X]  in 1 g
    Glycyrrhiza Glabra (UNII: 2788Z9758H) (Glycyrrhiza Glabra - UNII:2788Z9758H) Glycyrrhiza Glabra15 [hp_X]  in 1 g
    Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita15 [hp_X]  in 1 g
    Nutmeg (UNII: AEE24M3MQ9) (Nutmeg - UNII:AEE24M3MQ9) Nutmeg15 [hp_X]  in 1 g
    Lactose (UNII: J2B2A4N98G) (Anhydrous Lactose - UNII:3SY5LH9PMK) Lactose15 [hp_X]  in 1 g
    Black Mustard Seed (UNII: 8LTY55LQ8D) (Black Mustard Seed - UNII:8LTY55LQ8D) Black Mustard Seed15 [hp_X]  in 1 g
    Solanum Nigrum Whole (UNII: 0FMD6WV47M) (Solanum Nigrum Whole - UNII:0FMD6WV47M) Solanum Nigrum Whole15 [hp_X]  in 1 g
    Allylthiourea (UNII: 706IDJ14B7) (Allylthiourea - UNII:706IDJ14B7) Allylthiourea15 [hp_X]  in 1 g
    Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis15 [hp_X]  in 1 g
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 g
    Brazil Nut (UNII: XKR79OET1K) (Brazil Nut - UNII:XKR79OET1K) Brazil Nut15 [hp_X]  in 1 g
    Hazelnut, Unspecified (UNII: IW0OM96F6O) (Hazelnut, Unspecified - UNII:IW0OM96F6O) Hazelnut, Unspecified15 [hp_X]  in 1 g
    Peanut (UNII: QE1QX6B99R) (Peanut - UNII:QE1QX6B99R) Peanut15 [hp_X]  in 1 g
    Trout, Unspecified (UNII: 7TI7U5PF2U) (Trout, Unspecified - UNII:7TI7U5PF2U) Trout, Unspecified15 [hp_X]  in 1 g
    Cod, Unspecified (UNII: 8D6Q5LNG3D) (Cod, Unspecified - UNII:8D6Q5LNG3D) Cod, Unspecified15 [hp_X]  in 1 g
    Tuna, Unspecified (UNII: V2T3IHT3E2) (Tuna, Unspecified - UNII:V2T3IHT3E2) Tuna, Unspecified15 [hp_X]  in 1 g
    Salmon, Unspecified (UNII: 6122W2M0GB) (Salmon, Unspecified - UNII:6122W2M0GB) Salmon, Unspecified15 [hp_X]  in 1 g
    Herring, Unspecified (UNII: 34EX28T4C1) (Herring, Unspecified - UNII:34EX28T4C1) Herring, Unspecified15 [hp_X]  in 1 g
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride15 [hp_X]  in 1 g
    Solanum Lycopersicum (UNII: 0243Q4990L) (Solanum Lycopersicum - UNII:0243Q4990L) Solanum Lycopersicum15 [hp_X]  in 1 g
    Saccharin (UNII: FST467XS7D) (Saccharin - UNII:FST467XS7D) Saccharin15 [hp_X]  in 1 g
    Solanum Tuberosum (UNII: 2A8I57T4MX) (Solanum Tuberosum - UNII:2A8I57T4MX) Solanum Tuberosum15 [hp_X]  in 1 g
    Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae15 [hp_X]  in 1 g
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus10 [hp_X]  in 1 g
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Trisulfide10 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
    Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root10 [hp_X]  in 1 g
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 g
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root10 [hp_X]  in 1 g
    Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac10 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig10 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 g
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride10 [hp_X]  in 1 g
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 g
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum10 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice10 [hp_X]  in 1 g
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur10 [hp_X]  in 1 g
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens10 [hp_X]  in 1 g
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 g
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2315-128 g in 1 BOTTLE, GLASS
    2NDC:55714-2315-257 g in 1 BOTTLE, GLASS
    3NDC:55714-2315-07 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2315)