Extra Strength Tylenol® Severe Cough + Sore Throat Day

SPL v1

SPL

SPL Set ID 2e9540e4-bd1d-9370-e063-6294a90affcb

Route

ORAL

Published

Effective Date 2025-02-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (1000 mg) Dextromethorphan (30 mg)

Inactive Ingredients

Water Carboxymethylcellulose Sodium, Unspecified Fd&c Red No. 40 Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Benzoate Sucralose Propylene Glycol Glycerin Anhydrous Citric Acid Sorbitol

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-06

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Description

Drug Facts

Uses

temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
cough
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

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

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.

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 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

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

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

Questions Or Comments?

call 1-877-895-3665 (toll-free) or

215-273-8755 (collect)

When Using This Product

do not exceed recommended dose

Prinicipal Display Panel

NEW

NDC 50580-140-08

EXTRA STRENGHT TYLENOL ^®

FOR ADULTS

SEVERE COUGH + SORE THROAT

Acetaminophen,

Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant

HEAD+BODY ACHES
FEVER+ SORE THROAT
COUGH

DAY

COOLING CHERRY

8 fl oz (240 mL)

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.

If Pregnant Or Breast Feeding,

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

Active Ingredients(in Each 30 Ml)

Acetaminophen 1,000 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have

liver disease
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

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
cough
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Pain reliever/fever reducer

Cough suppressant

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

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

Allergy Alert (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.

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 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

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)

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or

215-273-8755 (collect)

When Using This Product (When using this product)

do not exceed recommended dose

Prinicipal Display Panel (PRINICIPAL DISPLAY PANEL)

NEW

NDC 50580-140-08

EXTRA STRENGHT TYLENOL ^®

FOR ADULTS

SEVERE COUGH + SORE THROAT

Acetaminophen,

Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant

HEAD+BODY ACHES
FEVER+ SORE THROAT
COUGH

DAY

COOLING CHERRY

8 fl oz (240 mL)

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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

Active Ingredients(in Each 30 Ml) (Active ingredients(in each 30 mL))

Acetaminophen 1,000 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "Purpose": "Pain reliever/fever reducer Cough suppressant", "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", "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", "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.", "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 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", "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": "anhydrous citric acid, carboxymethylcellulose sodium, FD&C red no 40, flavors, glycerin,microcrystalline cellulose and carboxymethylcellulose sodium,poloxamer, polyethylene glycol,propylene glycol, purified water,sodium benzoate, sorbitol, sucralose", "Questions or comments?": "call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "When using this product": "do not exceed recommended dose", "PRINICIPAL DISPLAY PANEL": "NEW NDC 50580-140-08 EXTRA STRENGHT TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT Acetaminophen, Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant HEAD+BODY ACHES FEVER+ SORE THROAT COUGH DAY COOLING CHERRY 8 fl oz (240 mL)", "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.", "If pregnant or breast-feeding,": "If pregnant or breast-feeding, ask a health professional before use.", "Active ingredients(in each 30 mL)": "Acetaminophen 1,000 mg Dextromethorphan HBr 30 mg", "Ask a doctor before use if you have": "liver disease 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:14.345541 · Updated: 2026-03-14T23:08:54.445441