Tylenol Extra Strength

Tylenol Extra Strength
SPL v2
SPL
SPL Set ID 65bf1556-f25a-9439-e053-2a91aa0a3194
Route
ORAL
Published
Effective Date 2018-02-21
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. 4 Free Acid Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Powdered Cellulose Propylene Glycol Shellac Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;500 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-12-04 Until 2026-03-31
Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

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
Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg if acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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

Other Information
  • store between 20-25°C (68-77°F)
  • see bottom of dispensit for lot number and expiration date
  • do not use if pouch is torn or damaged
Package Labeling:

Inactive Ingredients

carnauba wax*, 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

*contains one or more of these ingredients

Questions Or Comments?

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

Ask A Doctor Before Use 

if you have disease

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Ask A Doctor Or Pharmacist Before Use 

if you are taking the blood thinning drug warfarin

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg if acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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 
Drug Facts

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • see bottom of dispensit for lot number and expiration date
  • do not use if pouch is torn or damaged
Package Labeling:

Inactive Ingredients (Inactive ingredients)

carnauba wax*, 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

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

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

Ask A Doctor Before Use  (Ask a doctor before use )

if you have disease

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

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

Acetaminophen 500 mg

Ask A Doctor Or Pharmacist Before Use  (Ask a doctor or pharmacist before use )

if you are taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:58.273160 · Updated: 2026-03-14T23:02:48.423363