Tylenol® Extra Strength

SPL v1

SPL

SPL Set ID 42321456-d7dd-3b51-e063-6394a90ac292

Route

ORAL

Published

Effective Date 2025-10-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (960 mg)

Inactive Ingredients

Sucrose Anhydrous Citric Acid Potassium Sorbate Glycerin Xanthan Gum Microcrystalline Cellulose Carboxymethylcellulose Sodium Water Sorbitol Solution Sucralose

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-28

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

■ temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps

■ temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Warnings

Warnings

Directions

■ do not take more than directed (see overdose warning)

■ shake well before using

■ remove child protective cap

■ squeeze the dose into the dosing cup

■ mL = milliliter

adults and children 12 years and over	■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice. ■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor
children under 12 years	■ ask a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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 allergic to acetaminophen or any of the inactive ingredients in 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.

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: potassium 30 mg

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive Ingredients

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

NDC 50580-187-08

NEW

Extra Strength

TYLENOL ^®

^{FOR ADULTS}

Acetaminophen (960 mg per 30 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Adult Liquid

Pain Reliever

Dye-Free

Alcohol Free

8 fl oz (240 mL)

960 mg per 30 mL

Cherry Flavor

Stop Use and Ask A Doctor If

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

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 Ingredient (in Each 30 Ml)

Acetaminophen 960 mg

Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps

■ temporarily reduces fever

Section 42229-5 (42229-5)

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 (see overdose warning)

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Purpose

Pain reliever/fever reducer

Warnings

Warnings

Directions

■ do not take more than directed (see overdose warning)

■ shake well before using

■ remove child protective cap

■ squeeze the dose into the dosing cup

■ mL = milliliter

adults and children 12 years and over	■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice. ■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor
children under 12 years	■ ask a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Do Not Use (Do not use)

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 (Liver warning)

Overdose Warning (Overdose warning)

Other Information (Other information)

■ each 30 mL contains: potassium 30 mg

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

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 50580-187-08

NEW

Extra Strength

TYLENOL ^®

^{FOR ADULTS}

Acetaminophen (960 mg per 30 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Adult Liquid

Pain Reliever

Dye-Free

Alcohol Free

8 fl oz (240 mL)

960 mg per 30 mL

Cherry Flavor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Acetaminophen 960 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps ■ temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose (see overdose warning )", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "Purpose": "Pain reliever/fever reducer", "Warnings": "Warnings", "Directions": "■ do not take more than directed (see overdose warning) ■ shake well before using ■ remove child protective cap ■ squeeze the dose into the dosing cup ■ mL = milliliter adults and children 12 years and over ■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice. ■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.", "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 allergic to acetaminophen or any of the inactive ingredients in 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.", "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: potassium 30 mg ■ store between 20-25°C (68-77°F) ■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing ", "Inactive ingredients": "anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum", "Questions or comments?": "Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-187-08 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen (960 mg per 30 mL) Oral Suspension Pain Reliever-Fever Reducer Adult Liquid Pain Reliever Dye-Free Alcohol Free 8 fl oz (240 mL) 960 mg per 30 mL Cherry Flavor", "Stop use and ask a doctor if": "■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present 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 ingredient (in each 30 mL)": "Acetaminophen 960 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:22.241317 · Updated: 2026-03-14T23:10:44.597675