Label: INFANTS TEETHING- chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating

  • 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 February 14, 2014

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  • Active ingredients HPUS

    Chamomilla 6X

    Calcarea phosphorica 6X

    Coffea cruda 6X

    Belladonna 12X (calculated as 0.0000000000003% alkaloids)

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • Purpose

    Irritability

    Teething, dentition

    Sleeplessness

    Redness and pain

  • Uses

    Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce gum redness and pain.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • Warnings

    As with any drug, ask a doctor before use if pregnant or nursing.

    Stop use and ask a doctor if:

    • symptoms do not improve in 7 days
    • swelling, rash of fever develops
    • irritation, pain and redness worsens.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.

    Do not use

    • more often than directed
    • for more than 7 days in a row unless directed by a doctor or dentist
    • if your child has a known allergy to any ingredient in this product.

    Do not use if security seal is broken or missing.

  • Directions

    Allow 2 or 3 tablets to dissolve under the tongue 4 times a day, or as directed by a licensed health care professional. If the child is restless or wakeful, allow 2 tablets to dissolve under the tongue every hour for 6 doses, or as directed by a licensed health care professional. If preferred, tablets may be dissolved in a teaspoon of water and then given to the child. CVS/pharmacy Teething Tablets are very soft and will dissolve almost instantly in the mouth. Please note: if your child has been crying or is upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest.

  • Other information

    Store at room temperature (68°-77°F)

  • Inactive ingredients

    Dextrose, maltodextrin, corn starch, crospovidone, magnesium stearate, lactose.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INFANTS TEETHING 
    chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-860
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION6 [hp_X]
    COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_X]
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-860-03135 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/14/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(59779-860)
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