Sudafed Pe Sinus Congestion

Sudafed Pe Sinus Congestion
SPL v5
SPL
SPL Set ID a38fdfb8-db89-487f-9b68-aa9152b91f5f
Route
ORAL
Published
Effective Date 2019-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax D&c Yellow No. 10 Aluminum Lake Fd&c Red No. 40 Fd&c Yellow No. 6 Aluminum Oxide Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Powdered Cellulose Sodium Starch Glycolate Type A Talc Titanium Dioxide Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: PE;WL95 Shape: round Shape: oval Color: red Color: blue Size: 7 mm Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-17
Description

SUDAFED PE ® DAYTIME Drug Facts

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

SUDAFED PE ® DAYTIME Drug Facts

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Section 42229-5

SUDAFED PE ® DAYTIME

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

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

Section 50570-1

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.

Section 53414-9

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

Section 55105-1
Active ingredients (in each tablet) Purpose
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
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
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.
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 ® 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

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
Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Section 42229-5 (42229-5)

SUDAFED PE ® DAYTIME

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purpose
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
Purpose

Nasal decongestant

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
Do Not Use (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.
Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken
Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel (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

When Using This Product (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 (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:19.912284 · Updated: 2026-03-14T23:04:57.817577