Sudafed Sinus Congestion 12 Hour Tablet, Film Coated, Extended Release
FDA Label NDC 50580-242

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Sudafed Sinus Congestion 12 Hour (NDC 50580-242). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl 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

Otc - Do Not Use

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

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 yearsdo not use this product in children under 12 years of age

Other Information

  • each tablet contains: calcium 45 mg
  • store at 20-25°C (68-77°F) in a dry place
  • protect from light
  • do not use if blister unit is torn or broken
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

PREVIOUSLY SUDAFED® 12 HOUR
NDC 50580-242-01

SUDAFED®

SINUS
CONGESTION 12 HOUR

Pseudoephedrine HCl Extended-Release Tablets USP, 120 mg
Nasal Decongestant

actual size

MAXIMUM STRENGTH
SINUS PRESSURE
+ CONGESTION

10 COATED CAPLETS*
*CAPSULE-SHAPED TABLETS

NON-DROWSY

Principal Display Panel (Sudafed 01)

Principal Display Panel (Sudafed 01)

* Please review the disclaimer below.