FDA Label for Childrens Teething Relief
View Indications, Usage & Precautions
Childrens Teething Relief Product Label
The following document was submitted to the FDA by the labeler of this product Homeostasis Laboratories, Inc.. 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.
Otc - Active Ingredient
Active Ingredients | Purpose |
Calcarea phosphorica 6C, HPUS | Relieves slow and difficult teething |
Chamomilla 6C, HPUS | Relieves intense pains of teething |
Coffea cruda 6C, HPUS | Relieves intense pains of teething |
Rheum officinale 6C, HPUS | Relieves difficult teething |
"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.
Statement of Identity: Relief of pain associated with children's teething.
Uses
For the relief of pain and fever in children caused by teething.
Safe for children 4 months and older (if younger than 4 months consult your doctor first).
Warnings
- Do not use if outer package seal is broken.
- Stop use and consult a doctor if symptoms do not improve within 3 days, worsen or are accompanied by a fever over 101˚F.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Directions
Give child one tablet and allow to chew or dissolve in the mouth. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child.
Repeat every 4 hours as needed.
Other Information
- Safe to take with all other medications.
- Store at 68-77°F (20-25°C) and keep out of direct sunlight.
- Avoid humid or damp storage conditions. Close well when not in use.
Inactive Ingredients
Lactose, magnesium stearate (vegetable source).
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