Label: NIN JIOM PEI PA KOA- elm bark syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 10, 2011

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  • DESCRIPTION

    King to Nin Jiom Pei Pa Koa is a pleasant tasting natural herbal based liquid especially formulated for relief of minor discomfort and to protect irritated areas in sore mouth and sore throat.

    Pei Pa Koa contains No Alcohol, artificial flavors, colors, or preservatives.

  • INDICATIONS

    For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
  • DIRECTIONS:

    Adults and Children 2 years of age and older: 2 teaspoonfuls every 2 hours as needed or as directed by a doctor or dentist.
    Children under 2 years of age: Consult a doctor or dentist.
  • WARNINGS

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children.
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.
  • Active:

    Elm Bark 650 mg per teaspoon.
  • In a Sucrose Syrup and Honey base of herbal extracts consisting of:

    loquat leaf, fritillary, balloon flower root, snakegourd seed, sand root, senega root, tuckahoe, licorice root, ginger root, five flavored seed, and peppermint.
  • PURPOSE

    For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
  • Product Label

    PPKLabel

  • INGREDIENTS AND APPEARANCE
    NIN JIOM PEI PA KOA 
    elm bark syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57708-888
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ELM (UNII: 63POE2M46Y) (ELM - UNII:63POE2M46Y) ELM650 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    PLATYCODON GRANDIFLORUM LEAF (UNII: 2L64H2X8DY)  
    FRITILLARIA PRZEWALSKII BULB (UNII: 8B269H8XVH)  
    ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)  
    GLEHNIA LITTORALIS ROOT (UNII: 75447U56MI)  
    HONEY (UNII: Y9H1V576FH)  
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    LICORICE (UNII: 61ZBX54883)  
    GINGER (UNII: C5529G5JPQ)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    FU LING (UNII: XH37TWY5O4)  
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)  
    TRICHOSANTHES CUCUMERINA SEED (UNII: O6375G869C)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorHONEY (Herbal Honey Loquat Flavored) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57708-888-0224 in 1 CARTON
    1NDC:57708-888-01300 mL in 1 BOTTLE, GLASS
    2NDC:57708-888-0448 in 1 CARTON
    2NDC:57708-888-03150 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/01/2006
    Labeler - NIN JIOM MEDICINE MANUFACTORY (HK) LTD (686152166)
    Establishment
    NameAddressID/FEIBusiness Operations
    NIN JIOM MEDICINE MANUFACTORY (HK) LTD686152166manufacture
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