Label: FLUAID- menthol granule, for solution

  • 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 1, 2014

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  • ACTIVE INGREDIENT

    Active ingredients                Purpose

    Menthol 135 mg.................Oral Pain Reliever

  • PURPOSE

    Uses For the temporary relief of sore throat

  • WHEN USING

    When using this product

    • Do not exceed recommended dosage
  • ASK DOCTOR/PHARMACIST

    Stop use and ask a doctor if

    • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

  • DO NOT USE

    Do not use otherwise than as directed

  • WARNINGS

    In the case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • QUESTIONS

    • Questions? 1-510-887-1899 Monday to Friday, 8 am - 5 pm Pacific Standard Time
    • www.popus.com
  • PRINCIPAL DISPLAY PANEL


    Image of carton label


  • INDICATIONS & USAGE

    UsesFor the temporary relief of sore throat

  • DOSAGE & ADMINISTRATION

    Directions


    Adults and children 12 years of age and older
    		Place 1 bags in 6 oz of boiling water and stir. Allow liquid to cool, Drink up to 4 times daily or as directed by a doctor
    Children under 12 years of age
    		Ask A doctor
  • INACTIVE INGREDIENT

    Corydalis bungeana, Phragmites Root, Kudzu Root, Siler Root, Schizonepeta Flower, Lactose, Fragrant Angelica Root, Platycodon Root, Bupleurum Root, Perilla Leaf, and Apricot Seed

  • INGREDIENTS AND APPEARANCE
    FLUAID 
    menthol granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62003-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol270 mg  in 6 g
    Inactive Ingredients
    Ingredient NameStrength
    Angelica dahurica root (UNII: 1V63N2S972)  
    Lactose (UNII: J2B2A4N98G)  
    Bupleurum chinense root (UNII: BMA22623YK)  
    APRICOT (UNII: 269CJD5GZ9)  
    PUERARIA MONTANA VAR. CHINENSIS ROOT (UNII: FQN0D1U235)  
    Saposhnikovia divaricata root (UNII: 8H84LFK2QD)  
    SCHIZONEPETA TENUFOLIA SPIKE (UNII: 2FN3BA1MZE)  
    PLATYCODON GRANDIFLORUM LEAF (UNII: 2L64H2X8DY)  
    Perilla frutescens leaf (UNII: T4L5881Y68)  
    CORYDALIS BUNGEANA FLOWERING/FRUITING TOP (UNII: 93W3R296YH)  
    PHRAGMITES AUSTRALIS ROOT (UNII: BBJ7AOM815)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62003-002-3010 in 1 BOX
    13 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2010
    Labeler - PRINCE OF PEACE ENTERPRISES INC. (131132714)
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