Label: KIDS EAR 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 January 30, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Ferrum phosphoricum (Ferrosoferric phosphate) 30X.......................................sensitivity to touch

    Capsicum annuum (Cayenne pepper) 30X......................................................sensitivity to touch

    Pyrogenium (Pyrogen) 30X..........................................................................coldness and chilliness

    Arsenicum album (Arsenous oxide) 30X.........................................................burning sensation of the ear

    Belladonna (Deadly nightshade) 30X.............................................................fullness of the ear, night time calmative

  • REFERENCES

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

  • Uses

    This oral homeopathic medicine is made from a combination of ingredients traditionally used to help relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

  • Warnings

    Do not use if imprinted shrink seal neckband 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 0.75 mL orally.
    • Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.

    Age: Infants and children up to 9 years of age

    Dose: 0.75 mL

  • Other information

    Store at room temperature.

  • Inactive ingredients

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

  • REFERENCES

    *These statements have not been reviewed by the Food and Drug Administration. This product is manufactured using traditional homeopathic principles of dilution.

    RETAIN CARTON FOR COMPLETE INSTRUCTIONS

  • CARTON

    image of carton

  • INGREDIENTS AND APPEARANCE
    KIDS EAR RELIEF 
    ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-687
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 25 mL
    CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE30 [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 CATION (3+) - UNII:C96613F5AV) 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:59779-687-021 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/30/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-687)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!