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): 55714-4808-1
  • 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 December 7, 2020

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  • INDICATIONS & USAGE SECTION

    Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times a day or as directed by a health professional.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Hydrastis canadensis 11x, Aconitum napellus 15x, Baryta carbonica 15x, Baryta muriatica 15x, Capsicum annuum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona officinalis 15x, Glonoinum 15x, Graphites 15x, Hydrastis canadensis 15x, Kali bichromicum 15x, Kali muriaticum 15x, Lycopodium clavatum 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum acidum 15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

  • QUESTIONS SECTION

    newtonlabs.net -Questions? 800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

  • WARNINGS SECTION

    WARNINGS: 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

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    WARNINGS: Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • 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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4808
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE15 [hp_X]  in 1 mL
    BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE15 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM15 [hp_X]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM15 [hp_X]  in 1 mL
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES15 [hp_X]  in 1 mL
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE15 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN15 [hp_X]  in 1 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE15 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE15 [hp_X]  in 1 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE15 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 [hp_X]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF15 [hp_X]  in 1 mL
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA15 [hp_X]  in 1 mL
    VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4808-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/02/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-4808)
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