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
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Contains inactivated NDC Code(s)
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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2315 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:55714-2315-1 28 g in 1 BOTTLE, GLASS 2 NDC:55714-2315-2 57 g in 1 BOTTLE, GLASS 3 NDC:55714-2315-0 7 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2315)
