Label: SINUSITIS- arsenicum iodatum, bryonia, cistus canadensis, hepar sulph. calc., histaminum hydrochloricum, hydrastis, iodium, kali bic., kali iod., merc. iod. rub., merc. viv., nux vom., phosphorus, pulsatilla, sabadilla, sticta, verbascum, echinacea liquid

  • 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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  • PRODUCT NAME & INDICATIONS SECTION

    Sinusitis  Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

  • DIRECTION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

  • ACTIVE INGREDIENT SECTION

    Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Iodium 15x, Kali bic. 15x, Kali iod.15x, Merc. iod. rub. 15x, Merc. viv. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta 15x, Verbascum 15x , Echinacea 3x, Hydrastis 3x.

  • PURPOSE SECTION

    Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS? SECTION

    www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    SINUSITIS  
    arsenicum iodatum, bryonia, cistus canadensis, hepar sulph. calc., histaminum hydrochloricum, hydrastis, iodium, kali bic., kali iod., merc. iod. rub., merc. viv., nux vom., phosphorus, pulsatilla, sabadilla, sticta, verbascum, echinacea liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4418
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arsenic Triiodide (UNII: 3029988O2T) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Triiodide15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense15 [hp_X]  in 1 mL
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide15 [hp_X]  in 1 mL
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride15 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal15 [hp_X]  in 1 mL
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine15 [hp_X]  in 1 mL
    Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate15 [hp_X]  in 1 mL
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide15 [hp_X]  in 1 mL
    Mercuric Iodide (UNII: R03O05RB0P) (Mercuric Cation - UNII:ED30FJ8Y42) Mercuric Iodide15 [hp_X]  in 1 mL
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed15 [hp_X]  in 1 mL
    Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria15 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4418-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4418-259.14 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4418) , API MANUFACTURE(55714-4418)
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