Tylenol Extra Strength

SPL v1

SPL

SPL Set ID 4961695d-72f3-533a-e063-6294a90a5a29

Route

ORAL

Published

Effective Date 2026-01-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Carnauba Wax Propylene Glycol Powdered Cellulose Hypromellose, Unspecified Sodium Starch Glycolate Type A Shellac Titanium Dioxide Fd&c Red No. 40 Magnesium Stearate Polyethylene Glycol, Unspecified Aluminum Oxide

Identifiers & Packaging

Pill Appearance

Imprint: TYLENOL;500 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-30

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to:

■ the common cold

■ headache

■ backache

■ minor pain of arthritis

■ toothache

■ muscular aches

■ premenstrual and menstrual cramps

temporarily reduces fever

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 500 mg

Warnings

Warnings

Directions

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

adults and children 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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 allergic to acetaminophen or any of the inactive ingredients in this product

Drug Facts

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.

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

Other Information

■ store between 20-25°C (68-77°F)

■ do not use if blister unit is torn or broken

Inactive Ingredients

carnauba wax, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Questions Or Comments?

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

Principal Display Panel

NDC 50580-491-10

To re-order reference the NDC Code

TYLENOL ^®

FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT.

100 Caplets

500 mg each

10 Blister Cards with 10 Individual Blisters

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

■ the common cold

■ headache

■ backache

■ minor pain of arthritis

■ toothache

■ muscular aches

■ premenstrual and menstrual cramps

temporarily reduces fever

Section 34088-5 (34088-5)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Warnings

Warnings

Directions

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

adults and children 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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)

Drug Facts

Drug Facts

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:)

Other Information (Other information)

■ store between 20-25°C (68-77°F)

■ do not use if blister unit is torn or broken

Inactive Ingredients (Inactive ingredients)

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 50580-491-10

To re-order reference the NDC Code

TYLENOL ^®

FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT.

100 Caplets

500 mg each

10 Blister Cards with 10 Individual Blisters

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: ■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever", "34088-5": "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.", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain reliever/fever reducer", "55106-9": "Active ingredient (in each caplet) Acetaminophen 500 mg", "Warnings": "Warnings", "Directions": "■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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 allergic to acetaminophen or any of the inactive ingredients in this product", "Drug Facts": "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.", "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", "Other information": "■ store between 20-25°C (68-77°F) ■ do not use if blister unit is torn or broken", "Inactive ingredients": "carnauba wax, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.", "Questions or comments?": "Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-491-10 To re-order reference the NDC Code TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever - Fever Reducer Extra Strength FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT. 100 Caplets 500 mg each 10 Blister Cards with 10 Individual Blisters"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:23.682062 · Updated: 2026-03-14T23:12:38.341862