Indications and uses
temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION
- Manufacturer
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Effective date
- 2022-03-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:45
Label at a glance#
ProductSUDAFED PE DAY PLUS NIGHT SINUS CONGESTION
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections
Dosage and administration
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
Storage and handling
store between 20-25°C (68-77°F) do not use if carton or blister unit is opened or broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
OTC - DO NOT USE SECTION
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
OTC - WHEN USING SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 carton or blister unit is opened 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)
SPL UNCLASSIFIED SECTION
SUDAFED PE ® NIGHTTIME
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each tablet) | Purposes |
|---|---|
| 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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 carton or blister unit is opened 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
NDC 50580-736-01
SUDAFED PE®
DAY+NIGHT SINUS CONGESTION
Phenylephrine HCl
Nasal Decongestant
DAYTIME
NASAL CONGESTION
12 TABLETS, 10 mg EACH
actual
size
Diphenhydramine HCl, Phenylephrine HCl
Antihistamine, Nasal Decongestant
NIGHTTIME
NASAL CONGESTION
RUNNY NOSE
*small tablet size
8 ULTRATABS
®* TABLETS
TOTAL: 20 TABLETS
Products#
Every source-derived product name is available through these pages.
- SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION
- Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride
- Sudafed PE Congestion
- Phenylephrine Hydrochloride
- CARNAUBA WAX
- D&C YELLOW NO. 10 ALUMINUM LAKE
- ALUMINUM OXIDE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POWDERED CELLULOSE
- SODIUM STARCH GLYCOLATE TYPE A
- TALC
- TITANIUM DIOXIDE
- PHENYLEPHRINE
- SUDAFED PE Sinus Congestion Plus Allergy
- FD&C BLUE NO. 1 ALUMINUM LAKE
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-736 | 50580-736-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f41bb15e-4df3-2b9a-e053-2a95a90a645b | 36513fd5-a7bd-40ef-b396-5f92e7ea0b2c | 2023-02-07 | Warnings | 36513fd5-a7bd-40ef-b396-5f92e7ea0b2c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.