Label: CHILDRENS TEETHING RELIEF- tribasic calcium phosphate - matricaria recutita - arabica coffee bean - rheum officinale root - 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
    Calcarea phosphorica 6C, HPUSRelieves slow and difficult teething
    Chamomilla 6C, HPUSRelieves intense pains of teething
    Coffea cruda 6C, HPUSRelieves intense pains of teething
    Rheum officinale 6C, HPUSRelieves difficult teething

    "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 pain associated with children's teething.

  • PURPOSE

  • Uses

    For the relief of pain and fever in children caused by teething.

    Safe for children 4 months and older (if younger than 4 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 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 TEETHING RELIEF 
    tribasic calcium phosphate - matricaria recutita - arabica coffee bean - rheum officinale root - tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47242-0231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE6 [hp_C]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_C]
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT6 [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:47242-0231-11 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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