Label: SINUSIN (pulsatilla vulgaris and euphorbia resinifera resin and luffa operculata fruit and mercuric iodide and silver nitrate and calcium sulfide and sinusitisinum and influenza a virus a/singapore/6/86 (h1n1) hemagglutinin antigen (heat inactivated) and influenza a virus a/beijing/32/92 (h3n2) hemagglutinin antigen (heat inactivated) and influenza b virus b/panama/45/90 hemagglutinin antigen- heat inactivated liquid

  • Category: HUMAN OTC DRUG LABEL

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 14, 2011

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of the reach of children.
  • INDICATIONS AND USAGE

    For the temporary relief of:
    • Nasal Congestion
    • Rhinitis and Sinusitis
    • Cold and Flu Nasal Symptoms

  • WARNINGS

    If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.
  • DOSAGE AND ADMINISTRATION

    Adults and Children above 11 years: 10 drops orally 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.
  • ACTIVE INGREDIENTS

    Each 50ml contains: Pulsatilla 2X, Euphorbium officinarum 6X, Luffa operculata 6X, Mercurius iodatus ruber 6X, Influenzinum 8X, Argentum nitricum 10X, Hepar sulphuris calcareum 10X, Sinusitisinum 13X 0.5 ml each.
  • INACTIVE INGREDIENTS

    Ethanol, Purified Water USP
  • PURPOSE

    Nasal Congestion, Rhinitis and Sinusitis, Cold and Flu Nasal Symptoms
  • PRINCIPAL DISPLAY PANEL

    Sinusin Oral Drop.jpg
  • INGREDIENTS AND APPEARANCE
    SINUSIN 
    pulsatilla vulgaris and euphorbia resinifera resin and luffa operculata fruit and mercuric iodide and silver nitrate and calcium sulfide and sinusitisinum and influenza a virus a/singapore/6/86 (h1n1) hemagglutinin antigen (heat inactivated) and influenza a virus a/beijing/32/92 (h3n2) hemagglutinin antigen (heat inactivated) and influenza b virus b/panama/45/90 hemagglutinin antigen (heat inactivated) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-3250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS2 [hp_X]  in 50 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN6 [hp_X]  in 50 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 50 mL
    MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P) MERCURIC IODIDE 6 [hp_X]  in 50 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 50 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE10 [hp_X]  in 50 mL
    SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM13 [hp_X]  in 50 mL
    INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: DRA5YV248Q) (INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:DRA5YV248Q) INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)8 [hp_X]  in 50 mL
    INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: 0835GZ42BC) (INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:0835GZ42BC) INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)8 [hp_X]  in 50 mL
    INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: 790PSW8427) (INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:790PSW8427) INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)8 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-3250-450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2007
    Labeler - Heel Inc (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heel Inc102783016manufacture