Bronchial Cough Therapy Tablet, Orally Disintegrating
FDA Label NDC 17312-018

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 Bronchial Cough Therapy (NDC 17312-018). 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, uses, 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 - Active Ingredient

Active IngredientsPurpose
Antimonium tartaricum HPUS6c, 12c, 18cRattling cough
Coccus cacti HPUS6c, 12c, 18cCongestive cough
Drosera HPUS6c, 12c, 18cDry tickling cough
Echinacea HPUS6c, 12c, 18cImmune system support
Hepar sulphuris calcareum HPUS6c, 12c, 18cExpectorant
Pertussinum HPUS18cRecurring and Spasmodic coughing attacks
Spongia tosta HPUS6c, 12c, 18cDry barking cough

The letters HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

According to homeopathic indications these ingredients provide temporary relief of symptoms of Bronchial Cough such as: • coughing • mucous build-up • chest tightness and • chest soreness after diagnosis by a physician.

Warnings

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN.

  • This product is a not a fast acting (rescue) inhaler.
  • 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.

    • Stop use and ask a doctor if:

    • You experience worsening symptoms.
    • If symptoms last longer than 7 days.

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.

Other Information

  • 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.

Inactive Ingredients

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

* Please review the disclaimer below.