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  5. Label Information: Infants Teething Liquid

FDA Label for Infants Teething Liquid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS HPUS:
    2. PURPOSE
    3. REFERENCES
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. CARTON

Infants Teething Liquid 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 (German chamomile) 5C

Arnica montana (Leopard's bane) 5C

Borax (Sodium borate) 5C

Hypericum perforatum (St.John's wort) 5C


Purpose



Chamomilla (German chamomile) 5C .....................................................gum pain, restlessness, irritability and agitation

Arnica montana (Leopard's bane) 5C ......................................................toothache and fever

Borax (Sodium borate) 5C .....................................................................gum inflammation and diarrhea

Hypericum perforatum (St.John's wort) 5C ..............................................dental nerve pain


References



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


Uses



This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething:

  • gum inflammation
  • gum pain
  • fever
  • diarrhea
  • restlessness and irritability

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


Warnings




Otc - Do Not Use



Do not use if seal under bottle cap is broken or missing.


Otc - Stop Use



Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • Do not use more than directed.
  • Do not take with food.
  • Take 0.75 mL orally at the onset of pain.
  • Repeat every 15 minutes up to 4 times daily then reduce with improvement until pain subsides, or as directed by a healthcare professional.

    • Age: Infants and children 0 to 9 years of age

    Dose: 0.75 mL


Other Information



Store at room temperature.


Inactive Ingredients



Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.


* Please review the disclaimer below.