Label: HUMPHREYS BABY TEETHING RELIEF CHERRY SWIFT STRIPS- matricaria recutita, arabica coffee bean, tribasic calcium phosphate film, soluble

  • 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 September 6, 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 & irritability reliever

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

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

  • Uses:

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

  • Warnings:

    Do not use if packet seal is torn or broken.

  • 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:

    Open packet, tear in half along perforation. Peel from corner to

    expose strip. Place 1 strip on tongue and allow to dissolve. If

    needed, repeat every 2 hours up to 4 times per day. If child is

    persistently irritable, wakeful and restless, administer 1 strip

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

  • Inactive ingredients

    beet juice extract, carrageenan, glycerin, gum arabic, maltodextrin,

    natural flavor, oat fiber, pectin, polysorbate 80, stevia, vanillin, xylitol

  • QUESTIONS

    Questions or Comments?

    1-866-267-8710 or

    www.humphreysbaby.com

    Distributed by: Humphreys Pharmacal, Inc.

    East Hampton, CT 06424

    Made in USA

  • PRINCIPAL DISPLAY PANEL


    Cherry Strip Carton FC79


  • INGREDIENTS AND APPEARANCE
    HUMPHREYS BABY TEETHING RELIEF CHERRY SWIFT STRIPS  
    matricaria recutita, arabica coffee bean, tribasic calcium phosphate film, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0219-4103
    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
    beet juice (UNII: IOZ32L9H3O)  
    carrageenan (UNII: 5C69YCD2YJ)  
    glycerin (UNII: PDC6A3C0OX)  
    acacia (UNII: 5C5403N26O)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    oat bran (UNII: KQX236OK4U)  
    pectin (UNII: 89NA02M4RX)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    stevia rebaudiuna leaf (UNII: 6TC6NN0876)  
    vanillin (UNII: CHI530446X)  
    xylitol (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorpink (translucent pink) Scoreno score
    ShapeRECTANGLE (rectangle) Size22mm
    FlavorCHERRY (natural flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0219-4103-0018 in 1 CARTON
    11 in 1 PACKET
    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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