Nasal Decongestant Pe Tablet
FDA Label NDC 69168-272

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Nasal Decongestant Pe (NDC 69168-272). 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, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Phenylephrine HCl 10 mg

Purpose

Nasal Decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis sinus congestion and pressure

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

When Using This Product

do not use more than directed

Stop Use And Ask A Doctor If

you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever

Keep Out Of Reach Of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately

Directions

take every 4 to 6 hours do not take more than 6 doses in 24 hours
Adults and children 12 years of age and older:1 tablet
Children under 12 years of age: Consult a doctor

Inactive Ingredients

croscarmellose sodium, FD&C Red #40, FD&C Yellow #6, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

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