Label: KIDS RELIEF EAR RELIEF- ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album 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 April 13, 2017

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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

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  • Purpose

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

    Capsicum annuum (Cayenne pepper) 30X...........................................................sensitivity to touch, fullness of the ear

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

    Arsenicum album (Arsenous oxide) 30X...............................................................burning sensation of the ear, night time calmative

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  • REFERENCES

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

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  • Uses

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

    *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

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  • Warnings


    Do not use if imprinted shrink seal neckband on bottle 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. 

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  • Directions

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day. 

    Children 2 to 9 years old: 0.75 ml every 8 hours or 3 times a day. 

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  • Other information

    Store at room temperature.

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  • Inactive ingredients

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

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  • CARTON
  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF EAR RELIEF 
    ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9214
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 30 [hp_X]  in 25 mL
    CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE 30 [hp_X]  in 25 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF 30 [hp_X]  in 25 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+) 30 [hp_X]  in 25 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE, RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-9214-8 1 in 1 CARTON 10/26/2016
    1 25 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/26/2016
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-9214)
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