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Drug Facts
Tylenol Cold Plus Flu Plus Chest Congestion Tablet, Film Coated
FDA Label NDC 50580-584
Full FDA labeling including 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 Tylenol Cold Plus Flu Plus Chest Congestion (NDC 50580-584). 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, active ingredients (in each caplet), 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
Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Purpose
Pain reliever/fever reducer
Expectorant
Uses
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
■ 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 have ever had an allergic reaction to this product or any
of its ingredients
Ask A Doctor Before Use If You Have
■ liver disease
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
■ cough that occurs with too much phlegm (mucus)
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
Stop Use And Ask A Doctor If
■ pain 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
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 4 hours while symptoms last
■ do not take more than 10 caplets in 24 hours |
| Children under 12 years: | ■ ask a doctor |
Other Information
■
each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)
■
do not use if blister unit is torn or broken
Inactive Ingredients
croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, titanium dioxide, triacetin
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect).
Principal Display Panel
NEW
NDC 50580-584-24
TYLENOL ®
FOR ADULTS
COLD + FLU +
CHEST CONGESTION
Acetaminophen, Guaifenesin
Pain Reliever-Fever Reducer, Expectorant
• HEADACHE + BODY ACHES
• FEVER
• SORE THROAT
• MUCUS + CHEST CONGESTION
COOL COATED
Actual Size
24 CAPLETS
* Please review the disclaimer below.
