FDA Label for Teething

View Indications, Usage & Precautions

Teething Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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





Otc - Do Not Use



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

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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.


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