Label: SINU-S- echinacea, hydrastis canadensis, arsenicum iodatum, bryonia, cistus canadensis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, iodium, kali bichromicum, kali iodatum, mercurius iodatus ruber, mercurius vivus, nux vomica, phosphorus pulsatilla, sabadilla, sticta , verbascum thapsus, sinusitisinum liquid

  • NDC Code(s): 55714-4778-1
  • 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 symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

  • DOSAGE & ADMINISTRATION SECTION

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

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Iodium 15x, Kali bichromicum 15x, Kali iodatum 15x, Mercurius iodatus ruber 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta pulmonaria 15x, Verbascum thapsus 15x, Sinusitisinum 16x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

  • INACTIVE INGREDIENT SECTION

    I nactive 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

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

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    SINU-S 
    echinacea, hydrastis canadensis, arsenicum iodatum, bryonia, cistus canadensis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, iodium, kali bichromicum, kali iodatum, mercurius iodatus ruber, mercurius vivus, nux vomica, phosphorus pulsatilla, sabadilla, sticta , verbascum thapsus, sinusitisinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4778
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED15 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [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
    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 IODIDE - UNII:R03O05RB0P) 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
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS15 [hp_X]  in 1 mL
    SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM16 [hp_X]  in 1 mL
    LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA15 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4778-130 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(55714-4778)
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