Label: SAMBUCUS FLUCARE- aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top syrup

  • NDC Code(s): 53499-9803-5
  • 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 November 17, 2023

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  • Active Ingredient 

    Aconitum napellus 4X

    Eucalyptus globulus 2X

    Sambucus nigra 3X

    Bryonia 4X

    Eupatorium perfoliatum 6X

    Gelsemium sempervirens  4X

    Phosphorus 6X

    Ipecacuanha 3X

  • Inactive Ingredients

    Citric Acid

    Elderberry Extract

    Ethyl Alcohol

    Fructose

    Glycerin

    Lactose Monohydrate

    Natural Flavors

    Purified Water

  • Dosage & Administration

    Directions:

    For best results, use at first sign of symptoms.

    Use only with enclosed dosage cup

    Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10 mL) four times daily.
    Children 6-11 years of age: Take 1 teaspoon (5 mL) four times daily.
    Children under 6 years of age: Consult a physician.

  • Indication & Usage

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

  • Purpose

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

  • 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 Doctor

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

  • 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.
    This 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 immediately.

  • PRINCIPAL DISPLAY PANEL

    Sambucus Flucare_15803.jpg

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  • 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 syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9803
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 120 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 120 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 120 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 120 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 120 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    ALCOHOL (UNII: 3K9958V90M)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY (NATURAL RASPBERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9803-51 in 1 BOX10/03/2017
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/03/2017
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9803)
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