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Sudafed Sinus Congestion 12 Hour

Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Labeler
Kenvue Brands LLC
Label updated
2024-11-08
Retrieved
2026-09-07
Active ingredients
PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

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
Warnings

Label information

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

Label information

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

Label information

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

Label information

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 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

[Image in the official label — see DailyMed source]

DailyMed Set ID: d600b5d5-7d95-4ad6-a95b-6d73502743d7 · Version 4
NDC: 50580-242