Tylenol Extra Strength
86b6ac01-3866-4cd8-a1be-9babb6ff311b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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 fevers
Warnings
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
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
Other Information
• store between 20-25°C (68-77°F)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened
Package Labeling:
Inactive Ingredients
carnauba wax*, 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
*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.
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 Ingredients (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 menstrual cramps
• temporarily reduces fevers
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 of 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
Other Information (Other information)
• store between 20-25°C (68-77°F)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened
Package Labeling:
Inactive Ingredients (Inactive ingredients)
carnauba wax*, 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
*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.)
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 Ingredients (in Each Caplet) (Active ingredients (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: 2026-02-15T12:03:40.111938 · Updated: 2026-03-14T23:03:50.462651