Sudafed PE Sinus Congestion
- Dosage form
- TABLET, FILM COATED
- Labeler
- Kenvue Brands LLC
- Label updated
- 2024-11-08
- Retrieved
- 2026-09-07
- Active ingredients
- PHENYLEPHRINE HYDROCHLORIDE
Label information
Drug Facts
Active ingredient (in each tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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 dose
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 |
|
| children under 12 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
- do not use if blister unit is torn or broken
Inactive ingredients
carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions or comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
PREVIOUSLY SUDAFED PE
® CONGESTION
NDC 50580-437-02
SUDAFED PE®
SINUS
CONGESTION
Phenylephrine HCl, Nasal Decongestant
actual size
MAXIMUM STRENGTH
- SINUS PRESSURE
- SINUS CONGESTION
36 TABLETS
NON-DROWSY
10 mg
each
[Image in the official label — see DailyMed source]
DailyMed Set ID: 2ca08917-1a75-4365-8520-c083e6a4225a · Version 6
NDC: 50580-437