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

  • NDC Code(s): 53499-1693-5, 53499-1693-9
  • 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 3, 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 each 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 doctor

  • 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: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Ask a doctor

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

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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 breast-feeding, ask 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 right away.

  • PRINCIPAL DISPLAY PANEL

    LBN21900694_A08_BT_NIGHT_COUGH_8OZ_CTN_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    NIGHTIME COUGH AND BRONCHIAL 
    aconitum napellus, bryonia 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:53499-1693
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 120 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 120 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 120 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN6 [hp_C]  in 120 mL
    MEDICAGO SATIVA LEAF (UNII: HY3L927V6M) (MEDICAGO SATIVA LEAF - UNII:HY3L927V6M) MEDICAGO SATIVA LEAF1 [hp_X]  in 120 mL
    OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT1 [hp_X]  in 120 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 120 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:53499-1693-51 in 1 CARTON03/03/2023
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:53499-1693-91 in 1 CARTON03/03/2023
    2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/2023
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico SA DE CV812805901manufacture(53499-1693)
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