Label: PLEO REB- sus scrofa small intestine mucosa lymph follicle capsule

  • 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 January 6, 2010

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Antiemetic Medicine

    20 CAPSULES

  • Indications

    For temporary relief of occasional nausea or vomiting.

  • INGREDIENTS

    1 capsule contains 330 mg Peyer's Patches extract 4X in a base of lactose.

  • Inactive Ingredients

    Lactose, Capsule shells consist of Hypromellose (HPMC).

  • Tamper Evident

    Do not use this product if imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

  • DOSAGE

    1–3 capsules daily, either before breakfast or at bedtime.

  • 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 taking 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.

    Protect from light and heat.

  • SPL UNCLASSIFIED SECTION

    Made in Germany

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

    Manufactured By:
    Sanum-Kehlbeck,
    GmbH & Co. KG

    Rev. 05/2008

  • PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

    Pleo™ Reb
    CAPSULES 4X

    Homeopathic
    Antiemetic Medicine

    Indications: For temporary
    relief of occasional
    nausea or vomiting.

    20 CAPSULES

    PRINCIPAL DISPLAY PANEL - 20 Capsule Carton
  • INGREDIENTS AND APPEARANCE
    PLEO REB 
    sus scrofa small intestine mucosa lymph follicle capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sus scrofa small intestine mucosa lymph follicle (UNII: 308LM01C72) (sus scrofa small intestine mucosa lymph follicle - UNII:308LM01C72) sus scrofa small intestine mucosa lymph follicle4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    hypromellose (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-3001-11 in 1 CARTON
    120 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/19/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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