Label: TEETHING- chamomilla, arnica montana, borax, hypericum perforatum tablet, chewable

  • 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 May 1, 2013

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  • ACTIVE INGREDIENTS HPUS

    Chamomilla 5C

    Arnica montana 5C

    Borax 5C

    Hypericum perforatum 5C

  • PURPOSE

    Gum pain, irritability

    Teething, fever

    Gum inflammation, diarrhea

    Dental nerve pain

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • USES

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

  • WARNINGS


    Do not use

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

    Stop use and ask a doctor if

    • symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Do not use if imprinted tamper band is broken or missing.

  • DIRECTIONS

    Dissolve 2 to 3 tablets under the tongue 4 times per day. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child. If the child is restless or wakeful, 2 tablets every hour for 6 doses or as recommended by a doctor. Teething tablets are very soft and dissolve almost instantly under the tongue. Please note: if your baby has been crying or upset, your baby may fall asleep after using this product because the pain has been relieved and your child can rest.

     AGE DOSE
     infants and children up to 9 years of age 2 to 3 tablets

  • OTHER INFORMATION

    In case of emergency, contact a medical professional.

  • INACTIVE INGREDIENTS

    Lactose NF.

  • IMAGE CARTON LABEL

    image description

  • INGREDIENTS AND APPEARANCE
    TEETHING 
    chamomilla, arnica montana, borax, hypericum perforatum tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-209
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA5 [hp_C]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA5 [hp_C]
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE5 [hp_C]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM5 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-209-05135 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/01/2013
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-209)
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