Label: WHP BE GONE TEETHING TM- tribasic calcium phosphate - matricaria chamomilla - arabica coffee bean pellet

  • NDC Code(s): 68428-862-14, 68428-862-29
  • Packager: Washington Homeopathic Products
  • Category: HUMAN OTC DRUG LABEL

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 8, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENTS

    CALC PHOS

    CHAMOMILLA

    COFFEA CRUDA

  • USES

    To relieve the symptoms of irritability restlessness, backwardness in getting teeth and other symptoms associated with difficult dentition.

  • KEEP OUT OF REACH OF CHILDREN

    AS with all medications, keep out of reach of children.

  • INDICATIONS

    Indications:

    Calc phos 6c –troubled teething*

    Chamomilla 6c –distressed teething*

    Coffea cruda 6c –sensitive teething*

    ■ Irritability ■ Restlessness ■ Sleeplessness

    *These statements have not been reviewed by the Food and Drug Administration.

  • STOP USE AND ASK DOCTOR

    If symptoms persist or recur, discontinue use. If pregnant or nursing a baby, consult a licensed practitioner before using this product.

  • DIRECTIONS

    3 to 5 pills every 3 hours for 2 days. Then 3 to 5 pills morning and night for 2 weeks. Repeat as necessary.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose Pills

  • PRINCIPAL DISPLAY PANEL

    image of label

    image of box

  • INGREDIENTS AND APPEARANCE
    WHP BE GONE TEETHING  TM
    tribasic calcium phosphate - matricaria chamomilla - arabica coffee bean pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-862
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION6 [hp_C]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_C]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68428-862-291 in 1 PACKAGE05/08/2014
    1NDC:68428-862-1412000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/08/2014
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-862)