Label: PLEO CITRO- citric acid monohydrate tablet

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 26, 2012

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  • PURPOSE

    Homeopathic Medicine Citric Acid

  • Indications

    For symptoms of allergies and the common cold.

  • ACTIVE INGREDIENT

    INGREDIENTS

    One tablet contains 83.34 mg Acidum citricum 10X, 83.34 mg Acidum citricum 30X, 83.34 mg Acidum citricum 200X in a base of lactose, potato starch, magnesium stearate.

  • Tamper Evident

    Do not use this product if imprinted inner blister pack is broken.

  • DOSAGE

    1-3 × daily 1-2 tablets.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Sanum-Kehlbeck GmbH & Co. KG Hoya, Germany

  • SPL UNCLASSIFIED SECTION

    Distributed by: SANUM USA Corp. 1465 Slater Road Ferndale, WA 98248

  • PRINCIPAL DISPLAY PANEL - Blister Pack Carton

    Pleo® Citro
    TABLETS

    Homeopathic
    Medicine
    Citric Acid

    The original
    SANUM®
    brand remedies

    Indications: For symptoms of allergies and the common cold.

    80 TABLETS

    Principal Display Panel - Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    PLEO CITRO 
    citric acid monohydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-8003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) CITRIC ACID MONOHYDRATE200 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-8003-18 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/10/2012
    Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanum-Kehlbeck GmbH & Co. KG318386133MANUFACTURE(60681-8003)
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