Tylenol ®

Tylenol ®
SPL v16
SPL
SPL Set ID bb6533e5-e6a9-488c-b8ab-a6a06e87ede9
Route
ORAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Propylene Glycol Shellac Sodium Starch Glycolate Type A Titanium Dioxide Magnesium Stearate Polyethylene Glycol, Unspecified Powdered Cellulose Carnauba Wax Castor Oil Starch, Corn Fd&c Red No. 40 Aluminum Oxide Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;500;HOSPITAL Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1994-08-19 Until 2019-01-31
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 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 50570-1

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
Section 53414-9

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

Directions
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
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 carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
Inactive Ingredients

carnauba wax

contains one or more of these ingredients
, castor oil
, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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 50580-451-50

See New Warnings Information & Directions

TYLENOL ®

Pain Reliever

Fever Reducer

Acetaminophen

EXTRA

STRENGTH

For Adults

50 CAPLETS

500 mg each

Caplets

For Hospital and Government Use Only

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 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 50570-1 (50570-1)

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
Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Directions
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
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)

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 (Other information)
  • store between 20-25 °C (68-77 °F)
  • do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
Inactive Ingredients (Inactive ingredients)

carnauba wax

contains one or more of these ingredients
, castor oil
, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol
, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

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 50580-451-50

See New Warnings Information & Directions

TYLENOL ®

Pain Reliever

Fever Reducer

Acetaminophen

EXTRA

STRENGTH

For Adults

50 CAPLETS

500 mg each

Caplets

For Hospital and Government Use Only

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

Acetaminophen 500 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.296251 · Updated: 2026-03-14T23:07:36.685051