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 liquid
- NDC Code(s): 55714-4857-1
- 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 January 31, 2024
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Hydrastis canadensis 11x, Aconitum napellus 20x, Baryta carbonica 20x, Baryta muriatica 20x, Capsicum annuum 20x, Causticum 20x, Chenopodium anthelminticum 20x, Chininum sulphuricum 20x, Cinchona officinalis 20x, Glonoinum 20x, Graphites 20x, Hydrastis canadensis 20x, Kali bichromicum 20x, Kali muriaticum 20x, Lycopodium clavatum 20x, Phosphorus 20x, Pulsatilla 20x, Salicylicum acidum 20x, Tabacum 20x, Thiosinaminum 20x, Viola odorata 20x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- 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
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4857 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 20 [hp_X] in 1 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 20 [hp_X] in 1 mL BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE 20 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 20 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 20 [hp_X] in 1 mL DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES 20 [hp_X] in 1 mL QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE 20 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 20 [hp_X] in 1 mL NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 20 [hp_X] in 1 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 20 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 20 [hp_X] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 20 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 20 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 20 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 20 [hp_X] in 1 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 [hp_X] in 1 mL TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 20 [hp_X] in 1 mL ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA 20 [hp_X] in 1 mL VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA 20 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 20 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4857-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/2024 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-4857)
