Label: HEPAR SULFURIS SINUS pellet

  • 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 June 4, 2018

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Dissolve pellets under the tongue 3-4
    times daily. Ages 12 and older: 10 pellets.
    Ages 2-11: 5 pellets. Under age 2: Consult
    a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Hepar sulfuris (Liver of lime) 6X, Membrana sinus frontalis (Bovine mucous membrane lining the frontal sinus) 8X, Membrana sinus maxillaris (Bovine mucous membrane lining the maxillary sinus) 8X, Membrana sinus sphenoidalis (Bovine mucous membrane lining the sphenoidal sinus) 8X, Membrana sinuum paranasalium (Bovine mucous membrane lining the paranasal sinus) 8X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Sucrose, Lactose

  • PURPOSE

    Use: Temporary relief of sinus congestion.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Contains traces of lactose. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

  • QUESTIONS

    Questions? Call 866.642.2858
    Uriel, East Troy, WI 53120
    www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    HeparSulfurisSinusPellets

  • INGREDIENTS AND APPEARANCE
    HEPAR SULFURIS SINUS 
    hepar sulfuris sinus pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-5050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]
    BOS TAURUS NASAL MUCOSA (UNII: 343455G79K) (BOS TAURUS NASAL MUCOSA - UNII:343455G79K) BOS TAURUS NASAL MUCOSA8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-5050-21350 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-5050)
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