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| Product NDC Code | 64616-050 | ||||||||||||
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| Drug Name | Pediatric earache remedy |
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| 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] |
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| Active Ingredients |
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| Route | AURICULAR (OTIC) | ||||||||||||
| Dosage Form | LIQUID | ||||||||||||
| Labeler Name | Vitality Works, Inc | ||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Pediatric Earache Remedy Aconitum napellus 6X Belladonna 3X Chamonilla 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.Pediatric Earache Remedy 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.Pediatric 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.Pediatric Earache Remedy 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.
Purpose
Information about the drug product’s indications for use.Pediatric Earache Remedy 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.
Spl product data elements
Usually a list of ingredients in a drug product.Pediatric Earache Remedy Ear Drops GRAPEFRUIT 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
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.Pediatric 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.Pediatric Earache Remedy Keep this and all medicines out 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.Pediatric 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 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.
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