Tylenol Extra Strength

SPL v9

SPL

SPL Set ID c830320e-72ba-48ff-a4cd-250ac5650bf0

Route

ORAL

Published

Effective Date 2025-02-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-10

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:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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.

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

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

store between 20-25°C (68-77°F)
do not use if blister unit is torn or broken

Inactive Ingredients

carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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

500mg

NDC 50580-457-11

To re-order reference the NDC Code

TYLENOL ^®

FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

100 Caplets

500 mg each

10 Blister Cards

with

10 Individual Blisters

SMART PACKAGING

DESIGNED FOR HEALTH

CARE PROFESSIONALS

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

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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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.

Purpose

Pain reliever/fever reducer

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)

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

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)

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)

500mg

NDC 50580-457-11

To re-order reference the NDC Code

TYLENOL ^®

FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

100 Caplets

500 mg each

10 Blister Cards

with

10 Individual Blisters

SMART PACKAGING

DESIGNED FOR HEALTH

CARE PROFESSIONALS

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

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "Purpose": "Pain reliever/fever reducer", "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", "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": "store between 20-25°C (68-77°F) do not use if blister unit is torn or broken", "Inactive ingredients": "carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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": "500mg NDC 50580-457-11 To re-order reference the NDC Code TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever - Fever Reducer Extra Strength 100 Caplets 500 mg each 10 Blister Cards with 10 Individual Blisters SMART PACKAGING DESIGNED FOR HEALTH CARE PROFESSIONALS FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT.", "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.", "Active ingredient (in each caplet)": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.300812 · Updated: 2026-03-14T23:07:36.685051