Label: EQUATE BLACK ELDERBERRY COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sambucus 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 February 8, 2023

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  • Drug Facts

    Drug Facts

  • Active Ingredients

    Active ingredients (In each tablet) *Purpose
    Bryonia 6X HPUSFever, chills, scratchy throat, muscle soreness
    Gelsemium sempervirens 6X, 12X, 30X HPUSSneezing, non-productive cough, bronchial irritation
    Sambucus nigra 3X, 6X HPUSFever, nasal congestion, coughing
    Sulphur 12X HPUSSinus pressure, sore throat, nasal pressure
    Zincum gluconicum 2X, 6X HPUSNausea, tiredness, exhaustion, bronchial constriction

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

  • Purpose

    Bryonia - Fever, chills, scratchy throat, muscle soreness

    Gelsemium sempervirens - Sneezing, non-productive cough, bronchial irritation

    Sambucus nigra - Fever, nasal congestion, coughing

    Sulphur - Sinus pressure, sore throat, nasal pressure

    Zincum gluconicum - Nausea, tiredness, exhaustion, bronchial constriction

  • Uses*

    According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician.

    * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • Warnings

    Warnings

    A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.

    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 4 years of age unless directed by a physician. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur.

  • Pregnant or breast-feeding

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

  • 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.

  • Stop use and ask a doctor

    Stop use and ask a doctor if:

    • You experience worsening symptoms. • Any new symptoms appear. • Symptoms last longer than 7 days.

  • Directions

    Directions

    • Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue OR chew tablet and swallow. • Do not swallow tablet whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

  • Other information

    Other information

    • Do not use if blister seal is broken. • Store at room temperature 15o to 30o C (59o to 86o F). • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.

  • Inactive ingredients

    Inactive ingredients

    Black carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.

  • Principal Display Panel

    Carton

  • INGREDIENTS AND APPEARANCE
    EQUATE BLACK ELDERBERRY COLD AND FLU RELIEF 
    bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    Product Characteristics
    Colorpurple ((off purple off grey color with specks) ) Scorescore with uneven pieces
    ShapeROUNDSize10mm
    FlavorBERRY ((Elderberry)) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-046-141 in 1 CARTON06/22/2021
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/22/2021
    Labeler - WAL-MART STORES INC (051957769)