Earache Relief Tablet, Orally Disintegrating
FDA Label NDC 17312-025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Earache Relief (NDC 17312-025). 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 otc - active ingredient, otc - purpose, warnings, otc - pregnancy or breast feeding, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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