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SAMBUCUS FLUCARE (Nature's Way Products, Inc.)

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LOZENGE 1 BLISTER PACK in 1 CARTON (53499-5799-3) > 30 LOZENGE in 1 BLISTER PACK Label Information

Complete SAMBUCUS FLUCARE Information

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: 

    Aconitum napellus 4X

    Bryonia alba 4X

    Eucalyptus globulus 2X

    Eupatorium perfoliatum 2X

    Gelsemium sempervirens 4X

    Ipecacuanha 3X

    Phosphorus 6X

    Sambucus nigra 3X


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: European Elderberry extract, fructose, lactose monohydrate, magnesium stearate, malic acid, manitol, natural flavors, silica, sorbitol, sucrose.


  • DOSAGE & ADMINISTRATION

    Dosage and 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 doctor.


  • INDICATIONS & USAGE

    Indications and Usage:

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


  • WARNINGS

    Warnings:

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by a  high fever, headache, rash, nausea, vomiting, or a rash, consult a doctor promptly.

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

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

    These could be signs of a serious condition.

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

    Keep out of reach of children.

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


  • PREGNANCY 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.

    Ask the Doctor:

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by a  high fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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

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

    hese could be signs of a serious condition.


  • OVERDOSAGE

    Overdosage:

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


  • PURPOSE

    Purpose:

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


  • PRINCIPAL DISPLAY PANEL

    15799 Sambucus FluCare  (30 Lozenges)

    15799 Sambucus FluCare Loz_04.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 Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5799
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X]
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X]
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color purple Score no score
    Shape ROUND Size 16mm
    Flavor GRAPE (NATURAL GRAPE FLAVOR) Imprint Code C
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53499-5799-3 1 in 1 CARTON 10/01/2011 10/31/2018
    1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/01/2011 10/31/2018
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe North America, Inc. 831153908 manufacture(53499-5799)