Gencare Long-acting Cough Relief Capsule, Liquid Filled
FDA Label NDC 72090-063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Gencare Long-acting Cough Relief (NDC 72090-063). 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 active ingredient (in each liquid-filled capsule), purpose, use, warnings, ask a doctor before use if you have, directions, other informations, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Liquid-Filled Capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Directions

  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    •  age dose
     adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed
     children under 12 years do not use

Other Informations

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients

Polyethylene glycol 400, propylene glycol, pvp k30, propyl gallate, purified water, gelatin, glycerin, sorbitol sorbitan solution, FD& C Blue no. 1, FD &C Red no 40, propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol, titanium dioxide, tween 80

Questions Or Comments?

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