Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 58602-804

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Pseudoephedrine Hcl (NDC 58602-804). 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, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 (In Each Tablet)

Pseudoephedrine HCl USP 120 mg

Purpose

Nasal decongestant

Uses

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

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions


adults and children
12 years and over
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 years
do not use this product in children under 12 years of age

Other Information

  • Each tablet contains: calcium 36 mg
  • store at 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if the individual blister unit is open or torn
  • see side panel for lot number and expiration date
  • USP Dissolution Test pending

Inactive Ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

Questions Or Comments?

call 1-855-274-4122

Package Label-Principal Display Panel - 120 Mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

AUROHEALTH
NDC 58602-804-67
MAXIMUM STRENGTH
Pseudoephedrine HCl

Extended-Release Tablets USP

120 mg
Long-Acting Nasal Decongestant

SINUS PRESSURE+CONGESTION
NON-DROWSY
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS
12 HOUR

Package Label-principal Display Panel (120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets)

Package Label-principal Display Panel (120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets)

* Please review the disclaimer below.