Label: PEDOXAN EXTRACT- citrus unshiu peel, saposhnikovia root, acetaminophen, dextromethorphan hydrobromide granule

  • NDC Code(s): 73442-0014-1
  • Packager: I World Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 16, 2020

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  • ACTIVE INGREDIENT

    Citrus Unshiu Peel(KP)

    Saposhnikovia Root(KP)

    Acetaminophen

    Dextromethorphan Hydrobromide

  • PURPOSE

    minor aches and pain from colds, headache fever

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    for adults take 1 pouch per intake, 3 times a day, before or between meals

  • WARNINGS

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Atractylodes Rhizome(KP), Aurantium lmmature Fruit(KHP), Perilla Leaf(KP), Poria(KP)

    Platycodon Root(KP), Cnidium Rhizome(KP), Bupleurum Root(KP), Pueraria Root(KP)

    Schizonepeta Spike(KP), Angelica Decursiva Root(KHP), Ostericum Root(KP)

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PEDOXAN EXTRACT 
    citrus unshiu peel, saposhnikovia root, acetaminophen, dextromethorphan hydrobromide granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73442-0014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TANGERINE (UNII: KH3E3096OO) (TANGERINE - UNII:KH3E3096OO) TANGERINE1 g  in 3 g
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN0.06 g  in 3 g
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) (SAPOSHNIKOVIA DIVARICATA ROOT - UNII:8H84LFK2QD) SAPOSHNIKOVIA DIVARICATA ROOT1 g  in 3 g
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE0.00425 g  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73442-0014-13 g in 1 POUCH; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/16/2020
    Labeler - I World Pharmaceutical Co., Ltd. (688222857)
    Registrant - I World Pharmaceutical Co., Ltd. (688222857)
    Establishment
    NameAddressID/FEIBusiness Operations
    I World Pharmaceutical Co., Ltd688222857manufacture(73442-0014)
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