Extra Strength Tylenol Cold Plus Flu Multi-symptom Nighttime Liquid
FDA Label NDC 50580-212

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 Extra Strength Tylenol Cold Plus Flu Multi-symptom Nighttime (NDC 50580-212). 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 - purpose, uses, warnings, liver warning, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Warnings

→ Liver Warning

→ Sore Throat Warning

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Other

Drug Facts

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.

Otc - Purpose

Active ingredients (in each 30 mL)	Purpose
Acetaminophen 1000 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Uses

■ temporarily relieves these common cold/flu symptoms

■ minor aches and pains

■ headache
■ sore throat
■ cough
■ sneezing and runny nose

■ 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

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
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
■ 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

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers

Otc - When Using

When using this product

■ do not exceed recommended dose
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery

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)
shake well before using
mL = milliliter
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

adults and children

12 years and over

take 30 mL in the dosing cup provided every 6 hours while symptoms last
do not take more than 90 mL 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

each 30 mL contains: sodium 19 mg
store between 20-25°C (68-77°F)
do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with “TYLENOL” is broken or missing

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose
and carboxymethylcellulose sodium, poloxamer, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose