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SUDAFED PE SINUS CONGESTION

Dosage form
KIT
Labeler
Kenvue Brands LLC
Label updated
2024-11-08
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

SUDAFED PE ® DAYTIME

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
  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
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)

Label information

SUDAFED PE ® NIGHTTIME

Drug Facts

유효 성분

성분·작용

Active ingredients (in each tablet) Purpose
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • nasal congestion
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
  • temporarily relieves sinus congestion and pressure
Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Label information

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dose
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 4 hours
  • do not take more than 6 tablets in 24 hours
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, FD&C blue no. 1 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 ® DAY + NIGHT SINUS CONGESTION
NDC 50580-239-01

SUDAFED PE®

SINUS CONGESTION

Phenylephrine HCl
Nasal Decongestant

DAYTIME

  • NASAL
    CONGESTION

actual size

12 TABLETS 10 mg each

Diphenhydramine HCl, Phenylephrine HCl
Antihistamine, Nasal Decongestant

NIGHTTIME

  • NASAL CONGESTION
  • RUNNY NOSE

actual size

8 TABLETS | TOTAL: 20 TABLETS

[Image in the official label — see DailyMed source]

DailyMed Set ID: a38fdfb8-db89-487f-9b68-aa9152b91f5f · Version 5
NDC: 50580-239