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

Purpose

Nasal decongestant

Description

SUDAFED PE ® DAYTIME Drug Facts

Medication Information

Active Ingredient

Phenylephrine HCl 10 mg

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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

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

Description

SUDAFED PE ® DAYTIME Drug Facts

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

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

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.

Questions Or Comments?

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

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

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

Active Ingredient (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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

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)

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

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)

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

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.

Questions Or Comments? (Questions or comments?)

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

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

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies", "42229-5": "SUDAFED PE ® DAYTIME Drug Facts", "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)", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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": "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"}

Additional Information

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