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Sudafed Sinus Congestion Plus Cold Severe Day

Dosage form
TABLET, FILM COATED
Labeler
Kenvue Brands LLC
Label updated
2026-06-10
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

유효 성분

Acetaminophen 500 mg

Pseudoephedrine HCl 30 mg

성분·작용

Pain reliever/fever reducer

Nasal decongestant

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ nasal congestion

■ sinus congestion and pressure
■ helps clear nasal passages
■ promotes nasal and sinus drainage
■ temporarily reduces fever

Warnings

Warnings

Liver warning

This product contains acetaminophen. 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

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

Label information

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Label information

When using this product do not exceed recommended dose

Label information

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur

■ pain 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
These could be signs of a serious condition.

Label information

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

Label information

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
■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless
directed by a doctor
■ do not use for more than 10 days unless directed
by a doctor
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

candelilla wax, croscarmellose sodium, crospovidone, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, zinc stearate

제조사 문의

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

PRINCIPAL DISPLAY PANEL

NEW

NDC 50580-659-10

SUDAFED ®

SINUS

CONGESTION + COLD SEVERE

Acetaminophen,
Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Nasal Decongestant

• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES

actual size

NON-DROWSY

10 TABLETS

[Image in the official label — see DailyMed source]

DailyMed Set ID: 537e1a0d-820d-c3f7-e063-6294a90a56ea · Version 1
NDC: 50580-659