Label: CLARA- psyllium husk granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 26, 2011

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  • ACTIVE INGREDIENT

    active ingredient: psyllium husk powder, thistle
  • INACTIVE INGREDIENT

    inactive ingredient: Inulin power, Indigestible maltodextrin, Kelp power, Lactulose power, Rice bran fermented power, Green tea power, L-Cystine, Propolis, Yeast Extract(B-glucan), Curcumd longa power, DL-methionine, Vitamix, Papain
  • PURPOSE

    ■ Enhances Liver function, detoxification and anti-inflammatory effects
    ■ Intestinal toxic emissions and health
    ■ Removes constipation and bad breadth
    ■ Dietary Fiber warranty
    ■ Enhances blood pressure and immune system
    ■ Diabetes prevention
    ■ Reduces Cholesterol
    ■ Prevention of adult diseases and osteoporosis
    ■ Removes Gastrointestinal Disorders and stomach gas

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    Take 1-2 pack(s) two times daily with a full glass of water, preferably before a meal
  • WARNINGS

    ■ If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before
      use. Discontinue use and consult your doctor if any adverse reactions occur.
    ■ Please check the ingredients before taking if there are allergic or idiosyncratic symptoms
    ■ Do not take if the product of expiration date is expired
  • DOSAGE & ADMINISTRATION

    ■ After taking, first one or two weeks, stomach may feel uncomfortable due to nutritive functions. After that, should be oka
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    CLARA 
    psyllium husk granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76369-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.25 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    INULIN (UNII: JOS53KRJ01)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    KELP BASS (UNII: 24ZZ99M3KV)  
    lactulose (UNII: 9U7D5QH5AE)  
    RICE (UNII: 659G217HPG)  
    TEA LEAF (UNII: GH42T47V24)  
    CYSTINE (UNII: 48TCX9A1VT)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76369-1001-15 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/26/2011
    Labeler - Handock Cosmetics Inc (688037204)
    Registrant - Handock Cosmetics Inc (688037204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Handock Cosmetics Inc688037204manufacture