Label: COLDS AND FLU RESPONSE- anas barbariae, hepatis et cordis extractum, arsenicum album, baptisia tinctoria, bryonia, dulcamara, echinacea, echinacea purpurea, eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, kali muriaticum, lac defloratum, phosphorus, pulsatilla, sulphur, zincum aceticum, zincum carbonicum, zincum metallicum, zincum muriaticum, zincum oxydatum, zincum picricum, zincum valerianicum liquid

  • 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 September 12, 2016

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  • ACTIVE INGREDIENT

    HPUS active ingredients:​ Anas barbariae, hepatis et cordis extractum (50C, 100C, 200C), Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Lac defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum oxydatum, Zincum picricum, Zincum valerianicum. Equal volumes of each ingredient in 10X, 30X, 100X potencies, unless otherwise noted.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Alcohol 20%, (v/v) glycerin 8% (v/v), pure water base.

  • INDICATIONS & USAGE

    Indications: For temporary relief of: •body aches & pains •nasal congestion •headaches & fevers associated with the common cold and flu.

    Use according to label indications under standard homeopathic indications.

  • DOSAGE & ADMINISTRATION

    Directions: Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve. Before initial dose, depress pump 4-5 times or until primed. Consult a physician for use in children under 12 years of age.

  • WARNINGS

    Warnings: Stop use and ask a doctor if symptoms persist or worsen. If you are pregnant or breast feeding, consult a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep this and all medications out of reach of children.
  • OTHER SAFETY INFORMATION

    Other Information: Tamper resistant for your protection. Use only if safety seal is intact. Contains 20% Ethyl Alcohol by Volume. In case of accidental overdose, contact a healthcare professional immediately.

  • PURPOSE

    For temporary relief of:

    • body aches & pains
    • nasal congestion
    • headaches & fevers associated with the common cold and flu
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    COLDS AND FLU RESPONSE 
    anas barbariae, hepatis et cordis extractum, arsenicum album, baptisia tinctoria, bryonia, dulcamara, echinacea, echinacea purpurea, eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, kali muriaticum, lac defloratum, phosphorus, pulsatilla, sulphur, zincum aceticum, zincum carbonicum, zincum metallicum, zincum muriaticum, zincum oxydatum, zincum picricum, zincum valerianicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58066-7012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE50 [hp_C]  in 59.2 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59.2 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]  in 59.2 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 59.2 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP10 [hp_X]  in 59.2 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED10 [hp_X]  in 59.2 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA10 [hp_X]  in 59.2 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP10 [hp_X]  in 59.2 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 59.2 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59.2 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION10 [hp_X]  in 59.2 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 59.2 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10   in 59.2 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59.2 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59.2 mL
    ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 [hp_X]  in 59.2 mL
    ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 [hp_X]  in 59.2 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59.2 mL
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 [hp_X]  in 59.2 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 [hp_X]  in 59.2 mL
    ZINC PICRATE NONAHYDRATE (UNII: 0057VRD75N) (ZINC CATION - UNII:13S1S8SF37) ZINC PICRATE NONAHYDRATE10 [hp_X]  in 59.2 mL
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE10 [hp_X]  in 59.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58066-7012-759.2 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/28/2016
    Labeler - Beaumont Bio Med (070624288)
    Registrant - Beaumont Bio Med (070624288)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(58066-7012)
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