Indications and uses
temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache promotes nasal and sinus drainage temporarily reduces fever
Sudafed PE Pressure plus Pain plus Cough
- Manufacturer
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Effective date
- 2017-11-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:05:45
Label at a glance#
ProductSudafed PE Pressure plus Pain plus Cough
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Label structure9 sections
Dosage and administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets 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 is opened or if blister unit is broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold/flu symptoms:
- sinus congestion and pressure
- nasal congestion
- cough
- sore throat
- minor aches and pains
- headache
- promotes nasal and sinus drainage
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
SPL UNCLASSIFIED SECTION
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
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.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
| 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 is opened or if blister unit is broken
Inactive ingredients
carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, powdered cellulose, pregelatinized starch, sodium starch glycolate
Questions or comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
See New Warning
SINUS
NDC 50580-550-24
SUDAFEDPE®
PRESSURE+PAIN +COUGH
For
Adults
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant
SINUS PRESSURE
+ CONGESTION
SINUS HEADACHE
SORE THROAT
COUGH
NON-DROWSY
24 CAPLETS
‡ Actual Pill Size
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 4 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 4 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 4 | |
| acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 4 | |
| dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 4 | |
| phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 4 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | 4 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| powdered cellulose | INACTIVE INGREDIENT | SMD1X3XO9M | 4 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 4 |
Products#
Every source-derived product name is available through these pages.
- Sudafed PE Pressure plus Pain plus Cough
- Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
- Acetaminophen
- Dextromethorphan Hydrobromide
- dextromethorphan
- Phenylephrine Hydrochloride
- phenylephrine
- carnauba wax
- hypromellose, unspecified
- magnesium stearate
- microcrystalline cellulose
- powdered cellulose
- sodium starch glycolate type a potato
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-550 | 50580-550-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | DROPS / ORAL | NA | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, COATED / ORAL | 40.2 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SHAMPOO / TOPICAL | 3 %w/w | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / BUCCAL | 4.5 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | CAPSULE / ORAL | 2430 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | LIQUID / ORAL | NA | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg |
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 |
|---|---|---|---|---|---|---|
| e43bfaad-7919-bd1c-e053-2a95a90abac9 | dc3a3b2e-566a-421c-b09b-cf40329724a4 | 2022-07-25 | Warnings | dc3a3b2e-566a-421c-b09b-cf40329724a4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.