Label: BABY 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 January 6, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    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

    Chamomilla 6X...............................................................................................Irritability

    Calcarea phosphorica 6X..................................................................................Teething, dentition

    Coffea cruda 6X..............................................................................................Sleeplessness

    Belladonna 12X (calculated as 0.0000000000003% alkaloids)...............................Redness and inflammation

  • USES

    Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and inflammation of gums.*

    *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.

    Consult a physician if symptoms do not improve in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or 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 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.

  • STORAGE AND HANDLING

    Store at room temperature (68-77°F)

  • Inactive Ingredients

    Lactose

  • PRINCIPAL DISPLAY PANEL

    image of box

  • INGREDIENTS AND APPEARANCE
    BABY TEETHING 
    chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-372
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 135 
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE6 [hp_X]  in 135 
    COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_X]  in 135 
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE12 [hp_X]  in 135 
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-372-03135 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/06/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-372)