FDA Label for Earache Relief
View Indications, Usage & Precautions
Earache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trp Company. 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
Apis mellifica HPUS - 6x, 12x, 18x
Arnica montana HPUS - 6x, 12x, 18x
Belladonna HPUS - 6x, 12x, 18x
Calcarea phosphorica HPUS - 6x, 12x, 18x
Echinacea HPUS - 3x
Hepar sulphuris calcareum HPUS - 6x, 12x, 18x
Mercurius solubilis HPUS - 6x, 12x, 18x
HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Apis mellifica HPUS - Discomfort, Redness of external ear
Arnica montana - Bruised sensation in external ears
Belladonna HPUS - Fullness, Congestion
Calcarea phosphorica HPUS - Itching, Coldness, Irritability
Echinacea HPUS - Immune support
Hepar sulphuris calcareum HPUS - Sensitivity to water, wind, cold and touch
Mercurius solubilis - Swimmer’s ear irritation
Warnings
USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.
This product is intended to complement, not replace, standard medical treatment.
- Initial worsening of symptoms may occur.
- A physician should always be consulted to rule out serious causes.
- In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Directions
- Suitable for adults and children 12 years and above.
- Dissolve entire tablet under tongue.
- Do not chew or swallow whole.
- Take 1 tablet 3 times a day or as directed by a physician.
- Use up to 6 times a day as needed.
- Take at least 10 minutes before or at least 10 minutes after eating or drinking.
- Children under the age of 12: consult a physician before use.
- Homeopathic remedies may not be effective for everyone.
Other Information
- There are no known contraindications.
- Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
- Store in a cool dark location.
- EarAche Relief Fast Dissolving Tablets are homeopathic dilutions: see www.thereliefproducts.com for details.
Inactive Ingredients
Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.
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