Label: HUMPHREYS BABY TEETHING RELIEF VERY CHERRY- matricaria recutita, arabica coffee bean, tribasic calcium phosphate pellet

  • 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 October 11, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Chamomilla (chamomile) 3X HPUS

    Coffea cruda (coffee seed) 3X HPUS

    Calcarea phosphorica (calcium phosphate) 12X HPUS

  • Purpose

    Chamomilla (chamomile) 3X HPUS.....................pain and irritability reliever

    Coffea cruda (coffee seed) 3X HPUS..................calming aid

    Calcarea phosphorica (calcium phosphate) 12X....supports dentition

  • Uses

    Temporarily relieves minor pain, irritability and wakefulness associated with teething in infants.

  • Warnings

    Do not use if cap seal is broken or missing.

  • STOP USE

    Stop use and ask doctor if

    • symptoms persist for more than 7 days or if irritation persists
    • inflammation, fever or infection develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Place 1 to 3 pellets in 1/2 teaspoon of water and allow to dissolve.

    After dissolving, apply to child's gums. If needed, repeat every 2 hours

    up to 4 times per day. If preferred, mixture may be administered under the tongue.

    If child is persistently irritable wakeful and restless, administer 3 pellets before bed

    - repeat if necessary or as directed by a healthcare professional.

  • Inactive ingredients

    corn starch NF (non-GMO), natural fruit flavor, sucrose NF (sugar)

  • QUESTIONS


    Questions or Comments?

    1-866-267-8710 or

    www.humphreysbaby.com

    Distributed by: Humphreys Pharmacal, Inc.

    East Hampton, CT 06424

    Made in USA

    Not tested on animals

  • PRINCIPAL DISPLAY PANEL


    Cherry Pellet Carton FC73




  • INGREDIENTS AND APPEARANCE
    HUMPHREYS BABY TEETHING RELIEF VERY CHERRY 
    matricaria recutita, arabica coffee bean, tribasic calcium phosphate pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0219-3103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    matricaria recutita (UNII: G0R4UBI2ZZ) (matricaria recutita - UNII:G0R4UBI2ZZ) matricaria recutita3 [hp_X]
    arabica coffee bean (UNII: 3SW678MX72) (arabica coffee bean - UNII:3SW678MX72) arabica coffee bean3 [hp_X]
    tribasic calcium phosphate (UNII: 91D9GV0Z28) (calcium cation - UNII:2M83C4R6ZB) tribasic calcium phosphate12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    starch, corn (UNII: O8232NY3SJ)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (natural fruit flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0219-3103-001 in 1 CARTON
    1135 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2012
    Labeler - Humphreys Pharmacal, Incorporated (124620340)
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