BABY TEETHING (CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA) TABLET, ORALLY DISINTEGRATING [CVS PHARMACY]

BABY TEETHING (CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA) TABLET, ORALLY DISINTEGRATING [CVS PHARMACY]
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NDC 59779-372-03
Set ID d4a23ed6-d885-48ef-83e2-fb2c1223da5d
Category HUMAN OTC DRUG LABEL
Packager CVS PHARMACY
Generic Name
Product Class
Product Number
Application Number
  • 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)

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