SAMBUCUS FLUCARE (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERI

SAMBUCUS FLUCARE (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERI
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NDC 53499-9779-3
Set ID 48bdfe6b-53b7-4298-b64f-3c2b12fa01e0
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS

    Aconitum napellus 4X

    Eucalyptus globulus 2X

    Sambucus nigra 3X

    Bryonia 4X

    Eupatorium perfoliatum 6X

    Gelsemium sempervirens 4X

    Phosphorus 6X

    Ipecacuanha 3X

  • INACTIVE INGREDIENTS

    Elderberry extract

    fructose

    lactose monohydrate

    magnesium stearate

    malic acid

    manitol

    natural flavor

    silica

    sorbitol

    sucrose

  • Dosage & Administration

    Directions:

    Chew or dissolve lozenges in the mouth.

    Do not swallow lozenges whole.

    For best results, use at the first sign of symptoms:

    Adults and children 12 years of age and older: Take 1 chewable lozenge four times daily.
    Children 6-11 years of age: Take 1 chewable lozenges two times daily.
    Children under 6 years of age: Consult a physician.

  • Indications & Usage

    Temporarily relieves common flu symptoms: chills and fever, congestion, cough, headache, hoarseness, runny nose, sneezing, sore throat, stuffy nose, minor aches and pains. 

  • Purpose

    Temporarily relieves common flu symptoms: chills and fever, congestion, cough, headache, hoarseness, runny nose, sneezing, sore throat, stuffy nose, minor aches and pains.

  • Warnings

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

    Consult a physician promptly.

  • Ask 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. 

  • Pregnant or Breast feeding

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

    Keep Out of Reach of Children

    Keep out of reach of children.

  • Overdosage

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

  • PRINCIPAL DISPLAY PANEL

    15799-Sambucus FC Lozenge_A02.jpg

  • INGREDIENTS AND APPEARANCE
    SAMBUCUS FLUCARE 
    aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9779
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MANNITOL (UNII: 3OWL53L36A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize16mm
    FlavorGRAPE (NATURAL GRAPE FLAVOR) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9779-31 in 1 CARTON09/08/2017
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/08/2017
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9779)

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