TYLENOL Extra Strength
Acetaminophen · Tablet, Film Coated · Oral
Active ingredient
Active ingredient (in each caplet) Acetaminophen 500 mg
Purpose
Purpose Pain reliever/fever reducer
Uses
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
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. 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 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 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.
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
Ask a doctor before use
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor
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.
Pregnancy 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.
Directions
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
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?
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised Jul 22, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 21 products
TYLENOL Extra Strength NDC products (21)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1695 | Acetaminophen 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 50090-5469 | Acetaminophen 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 50090-0005 | Acetaminophen 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 67414-449 | Acetaminophen 500 mg/1 Tablet | Jones Healthcare Group - Packaging Services, Inc | OTC MONOGRAPH DRUG |
| 50580-472 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-937 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-491 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-490 | Acetaminophen 500 mg/1 Tablet, Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-469 | Acetaminophen 500 mg/1 Capsule, Liquid Filled | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-457 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-449 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-378 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-209 | Acetaminophen 500 mg/.95g Powder | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-187 | Acetaminophen 960 mg/30mL Suspension | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-108 | Acetaminophen 500 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 66715-9747 | Acetaminophen 500 mg/1 Tablet, Coated | Lil' Drug Store Products, Inc. | OTC MONOGRAPH DRUG |
| 53209-1001 | Acetaminophen 500 mg/1 Tablet, Film Coated | Morning Star OTC | OTC MONOGRAPH DRUG |
| 67751-167 | Acetaminophen 500 mg/1 Tablet, Film Coated | Navajo Manufacturing Company Inc. | OTC MONOGRAPH DRUG |
| 70264-027 | Acetaminophen 500 mg/1 Tablet | R J General Corporation | OTC MONOGRAPH DRUG |
| 73097-012 | Acetaminophen 500 mg/1 Tablet, Film Coated | Savings Distributors LLC | OTC MONOGRAPH DRUG |
| 85237-1946 | Acetaminophen 500 mg/1 Tablet, Film Coated | Select Consumer Group LLC | OTC MONOGRAPH DRUG |
TYLENOL Extra Strength recalls
- D-0121-2026 Nov 5, 2025 · Class II · Ongoing
Defective Container
Frequently asked questions
What is TYLENOL Extra Strength used for?
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
Who makes TYLENOL Extra Strength?
TYLENOL Extra Strength is listed by 9 labelers in the FDA NDC directory, including A-S Medication Solutions, Jones Healthcare Group - Packaging Services, Inc, Kenvue Brands LLC, Lil' Drug Store Products, Inc..
Has TYLENOL Extra Strength been recalled?
The FDA enforcement database lists 1 recall for TYLENOL Extra Strength, most recently D-0121-2026 (class ii): Defective Container