HAN HONEY LOQUAT SYRUP (MENTHOL) SYRUP [PRINCE OF PEACE ENTERPRISES INC.]

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HAN HONEY LOQUAT SYRUP (MENTHOL) SYRUP [PRINCE OF PEACE ENTERPRISES INC.]
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NDC 62003-888-85, 62003-888-86
Set ID 50bbf038-0667-4286-adde-619ce9406da7
Category HUMAN OTC DRUG LABEL
Packager PRINCE OF PEACE ENTERPRISES INC.
Generic Name
Product Class
Product Number
Application Number PART356
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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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