Sudafed Pe Head Congestion + Flu Severe

SPL v9

SPL

SPL Set ID 1e528f78-0ced-4a06-935a-84056c921727

Route

ORAL

Published

Effective Date 2020-08-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Yellow No. 5 Fd&c Yellow No. 6 Aluminum Oxide Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Carnauba Wax Polyethylene Glycol, Unspecified Titanium Dioxide Polysorbate 80

Identifiers & Packaging

Pill Appearance

Imprint: SUPE;WL92 Shape: oval Color: orange Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-06-17

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
- sinus congestion and pressure
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 the blood thinning drug warfarin

Section 53414-9

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

Section 55105-1

Active ingredients (in each tablet)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Directions

do not use more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours
children under 12 years	ask a doctor

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

Liver Warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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

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.

Other Information

contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive
store between 20-25°C (68-77°F)
do not use if carton or blister unit is opened or broken

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.

Inactive Ingredients

carnauba wax, croscarmellose sodium, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide

Questions Or Comments?

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

Principal Display Panel

PREVIOUSLY SUDAFED PE ^® PRESSURE + PAIN + COLD

NDC 50580-450-01

SUDAFED ^PE®

HEAD CONGESTION

+ FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Guaifenesin,

Phenylephrine HCl, Pain Reliever/Fever Reducer,

Cough Suppressant, Expectorant, Nasal Decongestant

actual

size

SINUS PRESSURE
HEADACHE
SORE THROAT
COUGH
CHEST CONGESTION

24 TABLETS

NON-DROWSY

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, cough or nasal congestion 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.

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, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Structured Label Content

Uses

temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
- sinus congestion and pressure
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 the blood thinning drug warfarin

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)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Directions

do not use more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours
children under 12 years	ask a doctor

Do Not Use (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

Liver Warning (Liver warning)

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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

Overdose Warning (Overdose warning)

Other Information (Other information)

contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive
store between 20-25°C (68-77°F)
do not use if carton or blister unit is opened or broken

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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 ^® PRESSURE + PAIN + COLD

NDC 50580-450-01

SUDAFED ^PE®

HEAD CONGESTION

+ FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Guaifenesin,

Phenylephrine HCl, Pain Reliever/Fever Reducer,

Cough Suppressant, Expectorant, Nasal Decongestant

actual

size

SINUS PRESSURE
HEADACHE
SORE THROAT
COUGH
CHEST CONGESTION

24 TABLETS

NON-DROWSY

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
pain, cough or nasal congestion 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.

Ask A Doctor Before Use If You Have (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, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to the common cold: nasal congestion headache minor aches and pains cough sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each tablet) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant", "Directions": "do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours children under 12 years ask a doctor", "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", "Liver warning": "This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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", "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.", "Other information": "contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive store between 20-25°C (68-77°F) do not use if carton or blister unit is opened or broken", "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.", "Inactive ingredients": "carnauba wax, croscarmellose sodium, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide", "Questions or comments?": "call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "PREVIOUSLY SUDAFED PE ® PRESSURE + PAIN + COLD NDC 50580-450-01 SUDAFED PE® HEAD CONGESTION + FLU SEVERE Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant actual size SINUS PRESSURE HEADACHE SORE THROAT COUGH CHEST CONGESTION 24 TABLETS NON-DROWSY", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion 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.", "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, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:18.405830 · Updated: 2026-03-14T23:04:55.371027