Label: TINNITUS- aconitum nap., baryta carb., baryta mur., capsicum, causticum, chenopodium anthelminticum, chininum sulphuricum, cinchona, glonoinum, graphites, hydrastis, kali bic., kali mur., lycopodium, phosphorus, pulsatilla, salicylicum ac, tabacum, thiosinaminum, viola odorata pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4585-1, 55714-4585-2 - 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
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x, Hydrastis 8x, Hydrastis 3x.
- 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
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
TINNITUS
aconitum nap., baryta carb., baryta mur., capsicum, causticum, chenopodium anthelminticum, chininum sulphuricum, cinchona, glonoinum, graphites, hydrastis, kali bic., kali mur., lycopodium, phosphorus, pulsatilla, salicylicum ac, tabacum, thiosinaminum, viola odorata pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4585 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 15 [hp_X] in 1 g Barium Carbonate (UNII: 6P669D8HQ8) (Barium Cation - UNII:V645272HLN) Barium Carbonate 15 [hp_X] in 1 g Barium Chloride Dihydrate (UNII: EL5GJ3U77E) (Barium Cation - UNII:V645272HLN) Barium Chloride Dihydrate 15 [hp_X] in 1 g Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 15 [hp_X] in 1 g Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 15 [hp_X] in 1 g Dysphania Ambrosioides (UNII: 4H5RSU087I) (Dysphania Ambrosioides - UNII:4H5RSU087I) Dysphania Ambrosioides 15 [hp_X] in 1 g Quinine Sulfate (UNII: KF7Z0E0Q2B) (Quinine - UNII:A7V27PHC7A) Quinine Sulfate 15 [hp_X] in 1 g Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 15 [hp_X] in 1 g Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin 15 [hp_X] in 1 g Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 15 [hp_X] in 1 g Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 15 [hp_X] in 1 g Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 15 [hp_X] in 1 g Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride 15 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 g Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 15 [hp_X] in 1 g Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf 15 [hp_X] in 1 g Allylthiourea (UNII: 706IDJ14B7) (Allylthiourea - UNII:706IDJ14B7) Allylthiourea 15 [hp_X] in 1 g Viola Odorata (UNII: AET12U8B74) (Viola Odorata - UNII:AET12U8B74) Viola Odorata 15 [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:55714-4585-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-4585-2 56.7 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(55714-4585)