Label: SAMBUCOL COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating

  • 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 April 12, 2022

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  • Active Ingredients

    Bryonia 6X

    Gelsemium sempervirens 6X, 12X, 30X

    Sambucus nigra 3X, 6X

    Sulphur 12X

    Zincum gluconicum 2X, 6X

  • Purpose

    Bryonia 6X................Muscle ache, headache, dry throat, cough

    Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing

    Sambucus nigra 3X, 6X...................Nasal congestion, coughing

    Sulphur 12X....................Nasal congestion and pressure, headache

    Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat

    * The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • Uses

    • Temporarily relieves cold & flu symptoms.
    • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.
    • Also temporarily relieves body aches associated with the flu.
  • Warnings

    Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

    Do not use for children under 4 years of age.

    Stop use and ask a doctor if:

    • Symptoms worsen
    • Any new symptoms appear
    • Fever lasts for more than three days
    • Respiratory symptoms persist for more than seven days

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

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.

    Adults and children 4 years of age and older - Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

  • Other Information

    • Do not use if blister seal is broken

    ​Active ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

  • Inactive Ingredients

    Black Carrot Extract (colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

  • PRINCIPAL DISPLAY PANEL

    NDC# 52053-0001-4

    Sambucol

    Black Elderberry

    Cold & Flu Relief

    90 Count Family Pack

    Take at the first sign of cold and flu symptoms

    **Temporary relief from:

    • Nasal & sinus congestion
    • Runny nose
    • Sore throat
    • Coughing
    • Sneezing

    90 Tablets

    Homeopathic

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    1

  • INGREDIENTS AND APPEARANCE
    SAMBUCOL COLD AND FLU RELIEF 
    bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52053-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mg
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 1 mg
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]  in 1 mg
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorpurple (off purple off grey color with specks) Scoreno score
    ShapeROUNDSize10mm
    FlavorBERRY (Elderberry) Imprint Code SCF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52053-0001-46 in 1 CARTON10/15/2021
    14500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/15/2021
    Labeler - PharmaCare US, Inc. (026889965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutritional Laboratories International Inc007306970manufacture(52053-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ion Labs Inc106499791pack(52053-0001)
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