Label: EAR RINGING- 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

  • NDC Code(s): 55714-2427-1
  • 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 November 25, 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 pellets by mouth (ages 6 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Htdrastis 6x, Aconitum nap. 10x, Baryta carb. 10x, Baryta mur. 10x, Capsicum 10x, Causticum 10x, Chenopodium anthelminticum 10x, Chininum sulphuricum 10x, Cinchona 10x, Glonoinum 10x, Graphites 10x, Hydrastis 10x, Kali bic. 10x, Kali mur.10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Salicylicum ac.10x, Tabacum 10x, Thiosinaminum 10x, Viola odorata 10x.

  • OTC - PURPOSE SECTION

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

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 1.800.448.7256

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

  • WARNINGS SECTION

    WARNINGS: Keep out of reach of children. Do no 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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • PACKAGE LABEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    EAR RINGING 
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2427
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 1 g
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 1 g
    BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE10 [hp_X]  in 1 g
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 1 g
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 1 g
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES10 [hp_X]  in 1 g
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE10 [hp_X]  in 1 g
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN10 [hp_X]  in 1 g
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 1 g
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 1 g
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE10 [hp_X]  in 1 g
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE10 [hp_X]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 1 g
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 [hp_X]  in 1 g
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF10 [hp_X]  in 1 g
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA10 [hp_X]  in 1 g
    VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA10 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2427-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2427)
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