Label: APO-PULM- onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole syrup

  • NDC Code(s): 59469-101-20, 59469-101-50
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 December 5, 2022

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  • ACTIVE INGREDIENT

    Ingredients:
    Allium cepa4X
    Bryonia cretica4X
    Hedera helix8X
    Hyoscyamus niger4X
    Kalium stibyltartaricum
    (Tartus stibiatus)    		6X
    Phosphorus10X
    Pulmonaria officinalis4X
    Polygala (Senega)4X

    In a base of Vinum liquorosum.

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 17% alcohol by volume.

  • Indications

    For relief of minor chest congestion with mucus. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 1 teaspoon up to 6 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®     GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 250 ml Bottle Box

    apo-PULM™

    Homeopathic Expectorant
    Syrup

    Homeopathic Medicine

    For relief of minor
    chest congestion
    with mucus

    8.5 fl. oz. (250ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 250 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    APO-PULM 
    onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion4 [hp_X]  in 125 mL
    Bryonia Dioica Root (UNII: 53UB5FH7CX) (Bryonia Dioica Root - UNII:53UB5FH7CX) Bryonia Dioica Root4 [hp_X]  in 125 mL
    Hedera helix Flowering Twig (UNII: 3D10KUA6BM) (Hedera helix Flowering Twig - UNII:3D10KUA6BM) Hedera helix Flowering Twig8 [hp_X]  in 125 mL
    Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger4 [hp_X]  in 125 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 125 mL
    Polygala senega Root (UNII: M7T6H7D4IF) (Polygala Senega Root - UNII:M7T6H7D4IF) Polygala senega Root4 [hp_X]  in 125 mL
    Antimony potassium tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5) Antimony potassium tartrate6 [hp_X]  in 125 mL
    Pulmonaria officinalis Whole (UNII: 483B0A2Y00) (Pulmonaria Officinalis Whole - UNII:483B0A2Y00) Pulmonaria officinalis Whole4 [hp_X]  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-101-201 in 1 BOX12/11/200802/03/2020
    1125 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:59469-101-501 in 1 BOX02/03/2020
    2250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/11/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-101)
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