Label: POLYPORUS PINICOLA pellet

  • 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 1, 2015

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  • ACTIVE INGREDIENT

    POLYPORUS PINICOLA HPUS 2X and higher

  • USES

    Chronic Fevers

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

  • INACTIVE INGREDIENTS

    Sucrose

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    POLYPORUS PINICOLA 
    polyporus pinicola pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOMITOPSIS PINICOLA FRUITING BODY (UNII: 30D02U2IRN) (FOMITOPSIS PINICOLA FRUITING BODY - UNII:30D02U2IRN) FOMITOPSIS PINICOLA FRUITING BODY2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-0355-0100 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:15631-0355-1200 in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:15631-0355-2400 in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:15631-0355-3750 in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:15631-0355-42500 in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:15631-0355-512500 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/12/2015
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo, Inc832534981wholesale drug distributor(15631-0355)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0355) , label(15631-0355)
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