Nasal Decongestant Pe Tablet
FDA Label NDC 84324-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Nasal Decongestant Pe (NDC 84324-010). 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 tablet), purpose, uses:, warnings:, ask a doctor before use if you have, stope use and ask a doctor if, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Phenylephrine HCl 10mg

Purpose

Nasal decongestant

Uses:

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stope Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever. 

Directions:

  • take 1 tablet every 4 hours
  • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information:

  • store between 20-25 °C (68-77 °F)
  • do not use if seal under cap is broken or missing

Inactive Ingredients:

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide

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