Tylenol Extra Strength
68b0be18-198e-48c7-a7a2-e81cbcf0fbe8
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 fever
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:
If a skin reaction occurs, stop use and seek medical help right away.
- 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
- skin reddening
- blisters
- rash
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over
|
|
| 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)
- 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 (toll-free) or (collect) 1-877-895-3665 215-273-8755
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.
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. Overdose warning:
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 menstrual cramps
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:
If a skin reaction occurs, stop use and seek medical help right away.
- 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
- skin reddening
- blisters
- rash
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over
|
|
| 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)
- 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 (toll-free) or (collect) 1-877-895-3665 215-273-8755
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.)
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. Overdose warning:
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: 2026-02-15T12:02:14.238205 · Updated: 2026-03-14T23:01:39.782884