Label: COLD AND FLU RELIEF- aconitum napellus, allium cepa, gelsemium supervirens, justica adhatoda, kali bichromicum, pulsatill nigricans, sanguinaria canadensis, sticta pulmonaria, camphora offcianarum tablet

  • 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 June 26, 2015

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  • Drug Facts

    Active ingredientPurpose
    Aconitum napellusinfluenza, colds, fever, congestion
    Allium cepacolds, sneezing, congestion, cough
    Gelsemium sempervirenscolds and flu, body aches
    Justicia adhatodacolds, congestion, runny nose
    Kali Bichromicumcold and sinus symptoms
    Pulsatilla nigricansbody aches, fever & chills
    Sanguinaria canadensissore throat, headache
    Sticta pulmonariacongestions, sneezing, cough
    Camphora Offcianarumcolds, cough & influenza

  • Uses

    Relieves cold and flu symptoms of

    • headache
    • body aches
    • sore throat
    • fever and chills
    • congestion
    • runny nose
    • cough
    • nausea
    • vomiting
    • diarrhea
  • Warnings

    Stop and ask a doctor if

    • fever persists for more than 3 days or exceeds 102 degrees
    • if cough persists for more than one week, comes back after a few days, or is accompanied by fever, rash or persistent headache. Persistent cough or high fever may be a sign of a serious health condition.
    • do not take this product for persistent chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician

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

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

  • Directions

    • do not use if printed blister foil backing is torn or missing
    • adults and children over the age of 12, chew one tablet and allow to dissolve in the mouth every 30 minutes until symptoms inprove, then reduce to every 4 hours
    • children 6-12 use one half the adult dosage
    • not recommended for children under the age of 6
  • Other information

    • for best results, take in a clean mouth
    • store at room temperature (65-80°F)
  • Inactive ingredients

    cellulose, croscarmellose sodium, dextrose, lactose, mangnesium stearate

  • PRINCIPAL DISPLAY PANEL

    Cold & Flu Indonesia carton

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU RELIEF 
    aconitum napellus, allium cepa, gelsemium supervirens, justica adhatoda, kali bichromicum, pulsatill nigricans, sanguinaria canadensis, sticta pulmonaria, camphora offcianarum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65808-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION4 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
    JUSTICIA ADHATODA LEAF (UNII: HH159XOV81) (JUSTICIA ADHATODA LEAF - UNII:HH159XOV81) JUSTICIA ADHATODA LEAF6 [hp_X]
    POTASSIUM CHROMATE (UNII: 5P0R38CN2X) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHROMATE6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]
    LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA6 [hp_X]
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITE (White) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65808-024-016 in 1 CARTON
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/21/2009
    Labeler - GMP Laboratories of America, Inc (876754375)
    Establishment
    NameAddressID/FEIBusiness Operations
    GMP Laboratories of America, Inc876754375MANUFACTURE(65808-024)
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