Label: RINOL-STROCHE- flubiprofen troche

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 31, 2024

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  • ACTIVE INGREDIENT

    flurbiprofen

  • PURPOSE

    for swelling and sore throat symptoms, temporarily reduces feber, relieves swelling and sore throat for tonsillitis/peritonsillitis

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    please see attached Drug Facts

  • WARNINGS

    please see attached Drug Facts

  • INACTIVE INGREDIENT

    d-mannitil, l-menthol, L-menthol

  • DOSAGE & ADMINISTRATION

    oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    RINOL-STROCHE 
    flubiprofen troche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLURBIPROFEN (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP) FLURBIPROFEN8.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize19mm
    FlavorImprint Code PHARMKN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0041-112 in 1 PACKAGE; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2024
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0041)