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Earache remedy - Medication Information

Product NDC Code 64616-045
Drug Name

Earache remedy

Type Brand
Pharm Class Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Potassium Compounds [CS],
Potassium Salt [EPC]
Active Ingredients
Aconitum napellus 6 [hp_x]/ml
Atropa belladonna 3 [hp_x]/ml
Matricaria recutita 6 [hp_x]/ml
Plantago major 3 [hp_x]/ml
Potassium chloride 3 [hp_x]/ml
Verbascum thapsus 6 [hp_x]/ml
Route AURICULAR (OTIC)
Dosage Form LIQUID
Labeler Name Vitality Works, Inc.
Packages
Package NDC Code Description
64616-045-02 1 bottle, dropper in 1 carton (64616-045-02) / 15 ml in 1 bottle, dropper (64616-045-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Earache Remedy Aconitum napellus 6X Belladonna 3X Chamomilla 6X Kali mur 3X Plantago major 3X Verbascum 6X

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Earache Remedy Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Earache Remedy A homeopathic combination for the temporary relief or earaches, inflammation of the external and internal ear. For the temporary relief of earches from congestion or swelling of middle ear or eustacian tubes.

Purpose

Information about the drug product’s indications for use.
Earache Remedy Aconitum napellus - relieves earache, hot, painful, swollen ear. Belladonna - relieves Otitis media, throbbing deep ear pain. Chamomilla - relieves eache, 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.

Spl product data elements

Usually a list of ingredients in a drug product.
Earache Remedy Ear Drops BENZALKONIUM CHLORIDE OLEA EUROPAEA LEAF WATER ACONITUM NAPELLUS ACONITUM NAPELLUS ATROPA BELLADONNA ATROPA BELLADONNA POTASSIUM CHLORIDE POTASSIUM CATION PLANTAGO MAJOR PLANTAGO MAJOR MATRICARIA RECUTITA MATRICARIA RECUTITA VERBASCUM THAPSUS VERBASCUM THAPSUS COBALT DISODIUM EDETATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Earache Remedy Label Carton

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Earache Remedy Keep this and all medicines out of reach of children.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Earache Remedy 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 your 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 accedental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but this is not intended for internal use.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API