FDA Label for Childrens Earache Relief
View Indications, Usage & Precautions
Childrens Earache 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 |
Aconitum napallus 6C, HPUS | Relieves sudden onset of ear pain |
Arsenicum album 6C, HPUS | Relieves runny nose & restlessness |
Chamomilla 6C, HPUS | Relieves irritability and pain |
Mercurius solubilis 6C, HPUS | Eliminates discharge from ears |
Pulsatilla 6C, HPUS | Relieves ear pain and weepy mood |
Silicea 6C, HPUS | Relieves ear pain |
"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 ear pain in children.
Uses
For the relief of acute inflammation of the ear, pain, high fever and discharge from the ears.
Safe for children 6 months and older (if younger than 6 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 persistent 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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