Label: NIGHTIME COUGH AND BRONCHIAL- aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup

  • NDC Code(s): 53499-0693-5, 53499-0693-9
  • Packager: Schwabe North America
  • 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 March 8, 2023

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  • Active Ingredient

    Acontinum napellus 3X

    Alfalfa 1X 

    Coffea cruda 6X 

    Avena sativa 1X 

    Bryonia 3X

    Hepar sulphuris calcareum 6C 

    Spongia tosta 3X 

    Stannum metallicum 6C 

  • Inactive Ingredient

    citric acid

    ethyl alcohol

    malt extract

    purified water

    sodium benzoate

    sucrose

  • Dosage & Administration

    Directions

    Shake well before use.

    Adults & Children 12 years of age and older: Take 2 teaspoons (tsp) (10ml) 1/2 hour before bedtime. Dose may be repeated if necessary.

    Children under 12 years of age: Consult a physician

  • Indications & Usage 

    Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
    Soothes the throat.

  • Purpose

    Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
    Soothes the throat.

  • Warnings

    Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.

    Consult a physician promptly.

  • Ask a doctor

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

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition. 

  • Pregnancy or breast feeding

    If pregnant or nursing, consult a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    21900694-Nighttime Cough Bronchial Syrup_A07.jpg

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  • INGREDIENTS AND APPEARANCE
    NIGHTIME COUGH AND BRONCHIAL 
    aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0693
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 118 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 118 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 118 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 118 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN6 [hp_C]  in 118 mL
    MEDICAGO SATIVA LEAF (UNII: HY3L927V6M) (MEDICAGO SATIVA LEAF - UNII:HY3L927V6M) MEDICAGO SATIVA LEAF1 [hp_X]  in 118 mL
    OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT1 [hp_X]  in 118 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BARLEY MALT (UNII: R3NBG8914U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0693-51 in 1 CARTON07/01/200401/31/2025
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:53499-0693-91 in 1 CARTON07/01/200409/30/2024
    2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/200401/31/2025
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico SA DE CV812805901manufacture(53499-0693)
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