Label: CHILDRENS EARACHE RELIEF- arsenic trioxide - matricaria recutita - aconitum napellus - pulsatilla vulgaris - mercurius solubilis - silicon dioxide - tablet, chewable

  • 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 November 14, 2012

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Aconitum napallus 6C, HPUSRelieves sudden onset of ear pain
    Arsenicum album 6C, HPUSRelieves runny nose & restlessness
    Chamomilla 6C, HPUSRelieves irritability and pain
    Mercurius solubilis 6C, HPUSEliminates discharge from ears
    Pulsatilla 6C, HPUSRelieves ear pain and weepy mood
    Silicea 6C, HPUSRelieves ear pain

    "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

    Statement of Identity: Relief of ear pain in children.

  • PURPOSE

  • Uses

    For the relief of acute inflammation of the ear, pain, high fever and discharge from the ears.

    Safe for children 6 months and older (if younger than 6 months consult your doctor first).

  • Warnings

    • Do not use if outer package seal is broken.
    • Stop use and consult a doctor if symptoms do not improve within 3 days, worsen or are accompanied by a persistent fever over 101˚F.
  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Directions

    Give child one tablet and allow to chew or dissolve in the mouth. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child.

    Repeat every 4 hours as needed.

  • Other information

    • Safe to take with all other medications.
    • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
    • Avoid humid or damp storage conditions. Close well when not in use.
  • Inactive Ingredients

    Lactose, magnesium stearate (vegetable source).

  • DO NOT USE

  • Questions? Call toll free or email us at:

    1-888-60-B-WELL (1-888-602-9355)

    info@homeostasislabs.com

  • PRINCIPAL DISPLAY PANEL

    Box image
  • INGREDIENTS AND APPEARANCE
    CHILDRENS EARACHE RELIEF 
    arsenic trioxide - matricaria recutita - aconitum napellus - pulsatilla vulgaris - mercurius solubilis - silicon dioxide - tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47242-0221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_C]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIUS SOLUBILIS6 [hp_C]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (Heart) Size5mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47242-0221-11 in 1 PACKAGE
    150 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Homeostasis Laboratories, Inc. (010569196)
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