Label: NATURCOKSINUM AM PM REAL RELIEF- anas barbariae, chamomilla, coffea cruda kit

  • Category: HUMAN OTC DRUG LABEL

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 January 16, 2013

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  • ACTIVE INGREDIENTS HPUS


    AM FORMULA

    Anas barbariae hepatis et cordis extractum (Autolysate of liver and heart of the duck) 200CK

    PM FORMULA

    Anas barbariae hepatis et cordis extractum (Autolysate of liver and heart of the duck) 200CK

    Chamomilla (German chamomile) 4C

    Coffea cruda (Coffee) 4C

  • REFERENCES

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

  • PURPOSE


    AM FORMULA

    Helps relieve flu-like symptoms: Fever, aches, pains and chills

    PM FORMULA

    Helps relieve flu-like symptoms: Fever, aches, pains and chills

    restlessness, irritability, nocturnal awakenings

    restlessness and sleeplessness

  • USES

    This homeopathic medicine temporarily helps relieve flu-like symptoms such as:

    - fever

    - chills

    - body aches and pains

  • WARNINGS


    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

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

    Keep out of reach of children.

  • DIRECTIONS

    - Chew tablets and let dissolve in mouth.

    - Do not use more than directed.

    - Repeat every 6 hours, up to 3 times and reduce intake with improvement or as directed by a health professional.

    Age
    		 Dose
    Adults and children 2 years of age and older
    		2 tablets
    Children under 2 years of age
    		Ask a doctor
  • OTHER INFORMATION

    - Store at room temperature (68 - 77F).

    - Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.

  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    NATURCOKSINUM AM PM  REAL RELIEF
    anas barbariae, chamomilla, coffea cruda kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6506
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6506-81 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 40 
    Part 21 BOTTLE 20 
    Part 1 of 2
    NATURCOKSINUM  FLU RELIEF DAYTIME REAL RELIEF
    anas barbariae hepatis et cordis extractum tablet, chewable
    Product Information
    Item Code (Source)NDC:60512-6006
    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 AUTOLYSATE200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6006-740 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/02/2013
    Part 2 of 2
    NATURCOKSINUM  FLU RELIEF NIGHTTIME REAL RELIEF
    anas barbariae hepatis et cordis extractum, chamomilla, coffea cruda tablet, chewable
    Product Information
    Item Code (Source)NDC:60512-6007
    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 AUTOLYSATE200 [hp_C]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_C]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6007-920 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/13/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6506)
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