Label: COUGH AND BRONCHIAL WITH ZINC- antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, spongia officinalis skeleton, roasted, zinc gluconate syrup

  • NDC Code(s): 53499-0193-5, 53499-0193-9
  • Packager: Schwabe North America, Inc
  • 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 August 1, 2022

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  • Active Ingredients

    ANTIMONIUM SULPHURATUM AUREUM 8X

    BRYONIA 3X

    DROSERA 4X

    EUCALYPTUS GLOBULUS 3X

    IPECACUANHA 3X

    SPONGIA TOSTA 3X

    ZINCUM GLUCONICUM 1X

    Inactive Ingredients

    Ethyl Alcohol

    Fructose

    Glycerin

    Purified Water

  • Dosage & Administration

    Shake well before use.
    Adults and children 12 years and older: Take 1-2 teaspoons (tsp) (5-10 mL) every 4 to 6 hours.

    Do not exceed 12 teaspoons in a 24 hour period.

    Children under 12 years of age:  Consult a doctor.

    Purpose

    Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

    Indications & Usage

    Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

  • Warning

    Do not use this product fore persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where coughis accompanied by excessive phlegm (mucus).

  • Ask doctor

    Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegn (mucus).

  • Stop Use 

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, if cough is accompanied by a fever, rash, or persistent headache.
    These could be signs of a serious condition.

  • Pregnancy or breast feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out reach of children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contact Posion Control Center immeditely.

  • PRINCIPAL DISPLAY PANEL

    21901193_A01-BT Cough Bronchical with Zinc Syrup.jpg

  • INGREDIENTS AND APPEARANCE
    COUGH AND BRONCHIAL WITH ZINC 
    antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, spongia officinalis skeleton, roasted, zinc gluconate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0193
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY PENTASULFIDE (UNII: 1433F1I86N) (ANTIMONY PENTASULFIDE - UNII:1433F1I86N) ANTIMONY PENTASULFIDE8 [hp_X]  in 237 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 237 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP4 [hp_X]  in 237 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF3 [hp_X]  in 237 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC4 [hp_X]  in 237 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 237 mL
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0193-91 in 1 BOX07/01/200404/30/2024
    1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:53499-0193-51 in 1 BOX07/01/200403/31/2024
    2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/200404/30/2024
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-0193)
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