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): 55714-4569-0, 55714-4569-1, 55714-4569-2
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION 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 June 1, 2011

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

  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with respiratory, gastro~intestinal, integumentary or vascular systems.

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  • 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. 

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  • 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.

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  • OTC - PURPOSE SECTION

      Formulated for symptoms associated with respiratory, gastro~intestinal, integumentary or vascular systems.

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  • INACTIVE INGREDIENT SECTION

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

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  • QUESTIONS SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256 

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  • 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.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

     If pregnant or breast-feeding, ask a doctor before use.

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

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  • 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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4569
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Egg (UNII: 291P45F896) (Egg - UNII:291P45F896) Egg 60 [hp_X]  in 1 g
    Fd&c Yellow No. 5 (UNII: I753WB2F1M) (Fd&c Yellow No. 5 - UNII:I753WB2F1M) Fd&c Yellow No. 5 60 [hp_X]  in 1 g
    D&c Yellow No. 10 (UNII: 35SW5USQ3G) (D&c Yellow No. 10 - UNII:35SW5USQ3G) D&c Yellow No. 10 60 [hp_X]  in 1 g
    Fd&c Yellow No. 6 (UNII: H77VEI93A8) (Food Yellow 3 Free Acid - UNII:G2B7JWK1GG) Fd&c Yellow No. 6 60 [hp_X]  in 1 g
    Carmoisine (UNII: DR4641L47F) (Carmoisine - UNII:DR4641L47F) Carmoisine 60 [hp_X]  in 1 g
    Amaranth (UNII: 37RBV3X49K) (Amaranth Acid - UNII:02J7X17ZUQ) Amaranth 60 [hp_X]  in 1 g
    Ponceau 4r (UNII: Z525CBK9PG) (Ponceau 4r - UNII:Z525CBK9PG) Ponceau 4r 60 [hp_X]  in 1 g
    Fd&c Red No. 3 (UNII: PN2ZH5LOQY) (Tetraiodofluorescein - UNII:1A878FZQ9B) Fd&c Red No. 3 60 [hp_X]  in 1 g
    Acid Red 1 (UNII: 3365R6427R) (Acid Red 1 - UNII:3365R6427R) Acid Red 1 60 [hp_X]  in 1 g
    Fd&c Blue No. 2 (UNII: L06K8R7DQK) (Fd&c Blue No. 2 - UNII:L06K8R7DQK) Fd&c Blue No. 2 60 [hp_X]  in 1 g
    Sodium Copper Chlorophyllin (UNII: 1D276TYV9O) (Sodium - UNII:9NEZ333N27) Sodium Copper Chlorophyllin 60 [hp_X]  in 1 g
    Acid Green 50 (UNII: 9B7E8Y9D0X) (Acid Green 50 - UNII:9B7E8Y9D0X) Acid Green 50 60 [hp_X]  in 1 g
    Sodium Benzoate (UNII: OJ245FE5EU) (Benzoic Acid - UNII:8SKN0B0MIM) Sodium Benzoate 60 [hp_X]  in 1 g
    Potassium Benzoate (UNII: 763YQN2K7K) (Potassium - UNII:RWP5GA015D) Potassium Benzoate 60 [hp_X]  in 1 g
    Propylparaben (UNII: Z8IX2SC1OH) (Propylparaben - UNII:Z8IX2SC1OH) Propylparaben 60 [hp_X]  in 1 g
    Sodium Dithionate (UNII: RPF7Z41GAW) (Sodium - UNII:9NEZ333N27) Sodium Dithionate 60 [hp_X]  in 1 g
    2-phenylphenol (UNII: D343Z75HT8) (2-phenylphenol - UNII:D343Z75HT8) 2-phenylphenol 60 [hp_X]  in 1 g
    Sodium Nitrite (UNII: M0KG633D4F) (Nitrite Ion - UNII:J39976L608) Sodium Nitrite 60 [hp_X]  in 1 g
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 [hp_X]  in 1 g
    Sodium Tripolyphosphate (UNII: 5HK03SA80J) (Tripolyphosphate Ion - UNII:5798IYA5AY) Sodium Tripolyphosphate 60 [hp_X]  in 1 g
    Aspartame (UNII: Z0H242BBR1) (Aspartame - UNII:Z0H242BBR1) Aspartame 60 [hp_X]  in 1 g
    Monosodium Glutamate (UNII: W81N5U6R6U) (Glutamic Acid - UNII:3KX376GY7L) Monosodium Glutamate 60 [hp_X]  in 1 g
    Beef (UNII: 4PIB2155QP) (Beef - UNII:4PIB2155QP) Beef 60 [hp_X]  in 1 g
    Pork (UNII: O138UB266J) (Pork - UNII:O138UB266J) Pork 60 [hp_X]  in 1 g
    Lamb (UNII: FOF26T73HA) (Lamb - UNII:FOF26T73HA) Lamb 60 [hp_X]  in 1 g
    Chicken (UNII: 0X8Q245Y7B) (Chicken - UNII:0X8Q245Y7B) Chicken 60 [hp_X]  in 1 g
    Turkey (UNII: 8E9NT44R8I) (Turkey - UNII:8E9NT44R8I) Turkey 60 [hp_X]  in 1 g
    Quahog, Unspecified (UNII: 226LY0AFR9) (Quahog, Unspecified - UNII:226LY0AFR9) Quahog, Unspecified 60 [hp_X]  in 1 g
    Crab Leg, Unspecified (UNII: S1VF61QLO9) (Crab Leg, Unspecified - UNII:S1VF61QLO9) Crab Leg, Unspecified 60 [hp_X]  in 1 g
    Oyster, Unspecified (UNII: S614XWR17V) (Oyster, Unspecified - UNII:S614XWR17V) Oyster, Unspecified 60 [hp_X]  in 1 g
    Shrimp, Unspecified (UNII: 1891LE191T) (Shrimp, Unspecified - UNII:1891LE191T) Shrimp, Unspecified 60 [hp_X]  in 1 g
    Scallop, Unspecified (UNII: D380C73WOU) (Scallop, Unspecified - UNII:D380C73WOU) Scallop, Unspecified 60 [hp_X]  in 1 g
    Amanita Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Fruiting Body - UNII:DIF093I037) Amanita Muscaria Fruiting Body 15 [hp_X]  in 1 g
    Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion 15 [hp_X]  in 1 g
    Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic 15 [hp_X]  in 1 g
    Anacardium Occidentale Fruit (UNII: 4A10JR4E7E) (Anacardium Occidentale Fruit - UNII:4A10JR4E7E) Anacardium Occidentale Fruit 15 [hp_X]  in 1 g
    Lycoperdon Utriforme Fruiting Body (UNII: K2A74U428F) (Lycoperdon Utriforme Fruiting Body - UNII:K2A74U428F) Lycoperdon Utriforme Fruiting Body 15 [hp_X]  in 1 g
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 15 [hp_X]  in 1 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 15 [hp_X]  in 1 g
    Cinnamon (UNII: 5S29HWU6QB) (Cinnamon - UNII:5S29HWU6QB) Cinnamon 15 [hp_X]  in 1 g
    Cynara Scolymus Leaf (UNII: B71UA545DE) (Cynara Scolymus Leaf - UNII:B71UA545DE) Cynara Scolymus Leaf 15 [hp_X]  in 1 g
    Alpine Strawberry (UNII: CG6IX3GCMU) (Alpine Strawberry - UNII:CG6IX3GCMU) Alpine Strawberry 15 [hp_X]  in 1 g
    Abrus Precatorius Seed (UNII: 3OM8I6L7CD) (Abrus Precatorius Seed - UNII:3OM8I6L7CD) Abrus Precatorius Seed 15 [hp_X]  in 1 g
    Glycyrrhiza Glabra (UNII: 2788Z9758H) (Glycyrrhiza Glabra - UNII:2788Z9758H) Glycyrrhiza Glabra 15 [hp_X]  in 1 g
    Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita 15 [hp_X]  in 1 g
    Nutmeg (UNII: AEE24M3MQ9) (Nutmeg - UNII:AEE24M3MQ9) Nutmeg 15 [hp_X]  in 1 g
    Lactose (UNII: J2B2A4N98G) (Anhydrous Lactose - UNII:3SY5LH9PMK) Lactose 15 [hp_X]  in 1 g
    Black Mustard Seed (UNII: 8LTY55LQ8D) (Black Mustard Seed - UNII:8LTY55LQ8D) Black Mustard Seed 15 [hp_X]  in 1 g
    Solanum Nigrum Whole (UNII: 0FMD6WV47M) (Solanum Nigrum Whole - UNII:0FMD6WV47M) Solanum Nigrum Whole 15 [hp_X]  in 1 g
    Allylthiourea (UNII: 706IDJ14B7) (Allylthiourea - UNII:706IDJ14B7) Allylthiourea 15 [hp_X]  in 1 g
    Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis 15 [hp_X]  in 1 g
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 15 [hp_X]  in 1 g
    Brazil Nut (UNII: XKR79OET1K) (Brazil Nut - UNII:XKR79OET1K) Brazil Nut 15 [hp_X]  in 1 g
    Hazelnut, Unspecified (UNII: IW0OM96F6O) (Hazelnut, Unspecified - UNII:IW0OM96F6O) Hazelnut, Unspecified 15 [hp_X]  in 1 g
    Peanut (UNII: QE1QX6B99R) (Peanut - UNII:QE1QX6B99R) Peanut 15 [hp_X]  in 1 g
    Trout, Unspecified (UNII: 7TI7U5PF2U) (Trout, Unspecified - UNII:7TI7U5PF2U) Trout, Unspecified 15 [hp_X]  in 1 g
    Cod, Unspecified (UNII: 8D6Q5LNG3D) (Cod, Unspecified - UNII:8D6Q5LNG3D) Cod, Unspecified 15 [hp_X]  in 1 g
    Tuna, Unspecified (UNII: V2T3IHT3E2) (Tuna, Unspecified - UNII:V2T3IHT3E2) Tuna, Unspecified 15 [hp_X]  in 1 g
    Salmon, Unspecified (UNII: 6122W2M0GB) (Salmon, Unspecified - UNII:6122W2M0GB) Salmon, Unspecified 15 [hp_X]  in 1 g
    Herring, Unspecified (UNII: 34EX28T4C1) (Herring, Unspecified - UNII:34EX28T4C1) Herring, Unspecified 15 [hp_X]  in 1 g
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride 15 [hp_X]  in 1 g
    Solanum Lycopersicum (UNII: 0243Q4990L) (Solanum Lycopersicum - UNII:0243Q4990L) Solanum Lycopersicum 15 [hp_X]  in 1 g
    Saccharin (UNII: FST467XS7D) (Saccharin - UNII:FST467XS7D) Saccharin 15 [hp_X]  in 1 g
    Solanum Tuberosum (UNII: 2A8I57T4MX) (Solanum Tuberosum - UNII:2A8I57T4MX) Solanum Tuberosum 15 [hp_X]  in 1 g
    Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae 15 [hp_X]  in 1 g
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 10 [hp_X]  in 1 g
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Trisulfide 10 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X]  in 1 g
    Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root 10 [hp_X]  in 1 g
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 10 [hp_X]  in 1 g
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 10 [hp_X]  in 1 g
    Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac 10 [hp_X]  in 1 g
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 10 [hp_X]  in 1 g
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig 10 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X]  in 1 g
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 10 [hp_X]  in 1 g
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X]  in 1 g
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum 10 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 10 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X]  in 1 g
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 10 [hp_X]  in 1 g
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens 10 [hp_X]  in 1 g
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root 3 [hp_X]  in 1 g
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Sucrose (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-4569-1 28 g in 1 BOTTLE, GLASS
    2 NDC:55714-4569-2 57 g in 1 BOTTLE, GLASS
    3 NDC:55714-4569-0 7 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4569)
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