Label: PLEO CITRO- citric acid monohydrate liquid

  • 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 November 7, 2011

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  • PURPOSE

    Homeopathic
    Liquid Medicine
    Citric Acid

    3.38 fl oz
    (100 mL)

  • Indications

    For symptoms of allergies and the common cold.

  • INGREDIENTS

    100mL solution contains Citric acid (10X, 30X, 200X, in equal amounts), in a base of purified water, alcohol 12.4% by volume.

  • Tamper evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

  • Dosage

    1-3 × daily 5-20 drops.

  • Warning

    If symptoms persist more than a few days, contact a licensed practitioner. As with any other 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 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

    Made in Germany

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

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

  • PRINCIPAL DISPLAY PANEL - 100 mL Carton

    Pleo® Citro
    Homeopathic
    Liquid Medicine
    Citric Acid

    The original
    SANUM®
    brand remedies

    Indications: For symptoms of
    allergies and the common cold.

    3.38 fl oz
    (100 mL)

    Principal Display Panel - 100 mL Carton
  • INGREDIENTS AND APPEARANCE
    PLEO CITRO 
    citric acid monohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-8001
    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]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-8001-11 in 1 CARTON
    1100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/02/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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