Pediatric Earache Remedy Liquid
FDA Label NDC 64616-050

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitality Works, Inc for the product Pediatric Earache Remedy (NDC 64616-050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding pediatric earache remedy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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