Tylenol ® - DailyMed Details

Tylenol ®

SPL v9

SPL

SPL Set ID 77a2dc96-73ee-4ca2-b1fe-406995802606

Route

ORAL

Published

Effective Date 2019-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg) Guaifenesin (650 mg)

Inactive Ingredients

Acetic Acid Alcohol Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance

Color: purple Color: brown Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-10-28

Description

Tylenol ® Cold plus Flu plus Cough Night Drug Facts

Medication Information

Description

Tylenol ® Cold plus Flu plus Cough Night Drug Facts

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose and sneezing
- cough
- sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
temporarily reduces fever

Section 42229-5

Tylenol ^® Cold plus Flu plus Cough

Night

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 15 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Doxylamine Succinate 6.25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Section 55106-9

Active ingredients (in each 15 mL) Purpose

Acetaminophen 325 mg Pain reliever/ fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Doxylamine Succinate 6.25 mg Antihistamine

Phenylephrine HCl 5 mg Nasal decongestant

Directions

do not take more than directed (see overdose warning)
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 4 hours while symptoms last do not take more than 150 mL in 24 hours, unless directed by a doctor
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. 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

each 15 mL contains: sodium 5 mg
store between 20-25°C (68-77°F).Do not refrigerate.
do not use if neck band imprinted with TYLENOL COLD+FLU+COUGH” or foil inner seal imprinted with “SAFETY SEAL® is broken or missing.

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

acetic acid, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-526-01

DAYTIME

NIGHTTIME

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

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

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
a breathing problem such as emphysema or chronic bronchitis
glaucoma
persistent or chronic cough such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose and sneezing
- cough
- sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
temporarily reduces fever

Section 42229-5 (42229-5)

Tylenol ^® Cold plus Flu plus Cough

Night

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 15 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Doxylamine Succinate 6.25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Section 55106-9 (55106-9)

Directions

do not take more than directed (see overdose warning)
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 4 hours while symptoms last do not take more than 150 mL in 24 hours, unless directed by a doctor
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. 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)

each 15 mL contains: sodium 5 mg
store between 20-25°C (68-77°F).Do not refrigerate.
do not use if neck band imprinted with TYLENOL COLD+FLU+COUGH” or foil inner seal imprinted with “SAFETY SEAL® is broken or missing.

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)

acetic acid, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-526-01

DAYTIME

NIGHTTIME

When Using This Product (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 (Stop use and ask a doctor if)

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

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
a breathing problem such as emphysema or chronic bronchitis
glaucoma
persistent or chronic cough such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:36.181434 · Updated: 2026-03-14T23:07:39.601528