Label: HAN HONEY LOQUAT SYRUP- menthol 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 April 26, 2014

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  • ACTIVE INGREDIENT

    • Menthol 0.1%......................................Oral Pain Reliever
  • INDICATIONS & USAGE

    Uses For the temporary relief of pain

    • due to minor irritation of the mouth and gumsdue to minor irritation of the mouth and gums
    • due to sore mouth
    • due to sore throat
  • WARNINGS

    • Do not exceed recommended dosage

    Stop use and ask a doctor if

    • sore throat is severe or persists for more than 2 days, or is accompanied by high fever, headache, rash, swelling, nausea, or vomiting
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • Children under 3 years of age

    • Do not use otherwise than as directed

    • Keep this and all drugs out of reach of children.
    • In the case of accidental overdose, seek professional assistance or contact a poison control center immediately.

    • If pregnant or breast-feeding, ask a health professional before use.
  • Directions

     Adults and children 12 years of age and older Take 2 teaspoonful every 4 to 6 hours or as directed by a doctor.
     Children over 3 years of age Take 1 teaspoonful every 4 to 6 hours or as directed by a doctor.
     Children under 3 years of age Not recommended

  • OTHER SAFETY INFORMATION

    • store at cool room temperature, less than 20°C (less than 68°F)
  • QUESTIONS

    • -510-887-1899 Monday to Friday, 8am - 5pm Pacific Standard Time
    • www.popus.com
  • INACTIVE INGREDIENT

    • Maltose, Honey, Loquat leaf, Grosvenor Momordica fruit, Fritillary bulb, Stemona root, Bitter Apricot seed, Hogfennel root, Licorice root
  • PRINCIPAL DISPLAY PANEL

    PPD of label

  • INGREDIENTS AND APPEARANCE
    HAN HONEY LOQUAT SYRUP 
    menthol syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62003-888
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTOSE (UNII: XJ6S9RV06F)  
    HONEY (UNII: Y9H1V576FH)  
    ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    FRITILLARIA CIRRHOSA BULB (UNII: 1MIE9LPB5I)  
    STEMONA SESSILIFOLIA ROOT (UNII: EKG8030U4N)  
    PEUCEDANUM PRAERUPTORUM ROOT (UNII: I5C2RXT7C1)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62003-888-866 in 1 BOX
    1NDC:62003-888-85252 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2014
    Labeler - PRINCE OF PEACE ENTERPRISES INC. (131132714)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tianjin Zhongyi Pharmaceutical Co Ltd421684143manufacture(62003-888)
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