Tylenol Extra Strength

Tylenol Extra Strength
SPL v7
SPL
SPL Set ID fba711c1-4e69-49b0-8994-97c455aebcb2
Route
ORAL
Published
Effective Date 2018-01-24
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 2018-01-24
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 menstual cramps • temporarily reduces lever

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours  Liver warning: 

  • 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 capletes every 6 hours while symptoms last
  • do not take more than 6 capletes 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.
Other Information
  • store between 20-25C (68-77F) 
  • do not use if pouch is torn or damaged. 
Package Labeling:

Overdose Warnings:

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.

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)

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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have
  • liver disease. 
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 menstual cramps • temporarily reduces lever

Purpose

Pain reliever/fever reducer

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours  Liver warning: 

  • 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 capletes every 6 hours while symptoms last
  • do not take more than 6 capletes 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.
Other Information (Other information)
  • store between 20-25C (68-77F) 
  • do not use if pouch is torn or damaged. 
Package Labeling:

Overdose Warnings: (Overdose warnings:)

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.

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)

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.)

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

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease. 
Ask A Doctor Or Pharmacist Before Use If You Are (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: 2026-02-15T12:06:29.807180 · Updated: 2026-03-14T23:09:18.179019