FDA Label for Pediatric Earache Remedy
View Indications, Usage & Precautions
Pediatric Earache Remedy Product Label
The following document was submitted to the FDA by the labeler of this product Vitality Works, 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.
Pediatric Earache Remedy
Aconitum napellus 6X
Belladonna 3X
Chamonilla 6X
Kali mur 3X
Plantago major 3X
Verbascum 6X
Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water
Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.
Keep this and all medicines out reach of children.
A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.
Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.
Aconitum napellus - relieves earach, hot, painful, swollen ear.
Belladonna - relieves otitis media, throbbing deep ear pain.
Chamomilla - relieves earache, soreness, swelling, otalgia.
Kali mur - relieves chronic catarrahal conditions of middle ear.
Plantago major - relieves earache, neuralgic earache, otalgia
Verbascum - Relieves catarrhs, otalgia with sense of obstruction.
* Please review the disclaimer below.