Tylenol ®

Tylenol ®
SPL v4
SPL
SPL Set ID 99e45e83-37a3-44df-9a2a-98ba7457a5bb
Route
ORAL
Published
Effective Date 2021-04-28
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 Polyethylene Glycol, Unspecified Powdered Cellulose Propylene Glycol Shellac Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL500 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01
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 aretaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you haveliver disease

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
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 pouch is torn or damaged
Inactive Ingredients

carnauba wax

contains one or more of these ingredients
, corn starch
, 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)

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

Principal Display Panel 500 Mg Caplet Pouch Box

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

50 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is torn or damaged.

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 aretaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver disease

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
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)

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 pouch is torn or damaged
Inactive Ingredients (Inactive ingredients)

carnauba wax

contains one or more of these ingredients
, corn starch
, 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? (Questions or comments?)

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

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

Principal Display Panel 500 Mg Caplet Pouch Box (PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Box)

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

50 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is torn or damaged.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:14.547143 · Updated: 2026-03-14T23:10:29.645873