SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]

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  • SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]

SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]
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NDC 52053-0001-1, 52053-0001-2
Set ID 4dc2088f-3f13-4e49-83e4-44c2a26d195f
Category HUMAN OTC DRUG LABEL
Packager PharmaCare US, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS:

    Bryonia 6X, Gelsemium Sempervirens 6X, 12X, 30X, Sambucus Nigra 3X, 6X, Sulphur 12X, Zincum Gluconicum 2X, 6X.

  • INDICATIONS:

    • Temporarily relieves cold and flu symptoms.

    • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and

       headache.

    • Also temporarily relieves fever, chills, and 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 more than 2 days or administer to children under 3 years of age unless directed by a physician. 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 using.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if blister seal is broken. 

  • 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 until symptoms are gone. Children under 4 years of age consult a doctor before use. 

  • INACTIVE INGREDIENTS:

    Black Carrot Colorant, Natural, Croscarmellose Sodium, Elderberry Flavor, Natural, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sucrose

  • KEEP OUT OF REACH OF CHILDREN:

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

  • INDICATIONS:

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

  • QUESTIONS:

    PharmaCare US Inc.

    P.O. Box 122950

    San Diego CA  92112

    Questions? Comments?

    Visit our website

    www.sambucolUSA.com

    or call 1-866-613-5057

  • PACKAGE LABEL DISPLAY:

    NDC# 52053-0001-2
    Sambucol
    BLACK ELDERBERRY
    COLD & FLU RELIEF
    TAKE AT THE FIRST
    SIGN OF COLD AND
    FLU SYMPTOMS
    Fast temporary relief from:
    Nasal & sinus congestion
    Runny nose
    Sore Throat
    Coughing
    Sneezing
    Chills & fever
    30 QUICK DISSOLVE TABLETS
    HOMEOPATHIC

    Sambucol

  • 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
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS 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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    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:52053-0001-22 in 1 CARTON06/30/2017
    1NDC:52053-0001-14500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/26/2013
    Labeler - PharmaCare US, Inc. (026889965)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(52053-0001) , api manufacture(52053-0001) , label(52053-0001) , pack(52053-0001)
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