Sudafed Sinus Congestion Plus Cold Severe Day Tablet, Film Coated
FDA Label NDC 50580-659

21 label sections · Submitted to the FDA by Kenvue Brands Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Sudafed Sinus Congestion Plus Cold Severe Day (NDC 50580-659). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, liver warning, allergy alert, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Warnings

→ Liver Warning

→ Allergy Alert

→ Sore Throat Warning

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Principal Display Panel

Other

Drug Facts

Otc - Active Ingredient

Acetaminophen 500 mg

Pseudoephedrine HCl 30 mg

Otc - Purpose

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

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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not exceed recommended dose

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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