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
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

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
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
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

Description

Drug Facts

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

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.

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.

Questions Or Comments?

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

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
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
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

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

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.

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.

Questions Or Comments? (Questions or comments?)

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

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