Label: EARACHE KIDS RELIEF- ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna 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 May 31, 2010

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  • ACTIVE INGREDIENTS HPUS

    Ferrum phosphoricum (Ferrosoferric phosphate) 30X

    Capsicum annuum (Cayenne pepper) 30X

    Pyrogenium (Pyrogen) 30X

    Arsenicum album (Arsenous oxide) 30X

    Belladonna (Deadly nightshade) 30X

  • PURPOSE

    Inflammation and fever.

    Acute pain and pressure in the ears.

    Infection and fever.

    Burning pain in the ears.

    Throbbing pain and inflammation.

  • REFERENCES

    This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

  • USES

    This homeopathic medicine helps relieve symptoms associated with earaches:

    - throbbing pain

    - inflammation

    - pressure in ears

    - fever

  • WARNINGS


    Do not use if seal is broken or missing.

    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

    Keep out of reach of children.

  • DIRECTIONS

    Do not use more than directed.

    Do not take with food.

    Take .75 ml orally.

    Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.


    Infants and children 0 to 9 years of age: .75 ml

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    image of carton label

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    EARACHE KIDS RELIEF 
    ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9063
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 25 mL
    RED PEPPER (UNII: 6M47G7C4SY) (RED PEPPER - UNII:6M47G7C4SY) RED PEPPER30 [hp_X]  in 25 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 25 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE30 [hp_X]  in 25 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE, RASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9063-81 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2008
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture
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