Tylenol Extra Strength
500 mg · tablet, film coated
- Available without prescription
- Active substance
- acetaminophen
- Made by
- Kenvue Brands LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-06-15
Pain reliever/fever reducer
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
Full directions ↓With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
Every line above is selected, not written, from the official label. Nothing is reworded. US National Library of Medicine
What it is for
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
From the official label · 2026-06-15 · US National Library of Medicine
Do not take it if
- 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
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
Ask a doctor before use if you have liver disease
Quoted from the official label, section “OTC — Ask Doctor”.
Ask a pharmacist first if
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.
Stop and get help 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.
Quoted from the official label, section “OTC — Stop Use”.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
How to store it
- store between 20-25°C (68-77°F)
- do not use if pouch is torn or damaged
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Pain reliever/fever reducer
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
contains one or more of these 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
Quoted from the official label, section “Inactive Ingredients”.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
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Details
| Made by | Kenvue Brands LLC · United States |
|---|---|
| Active substance | acetaminophen |
| Strength | 500 mg |
| Form | tablet, film coated |
| NDC | 50580-449 |
| SPL Set ID | 59773893-09a8-47a2-943a-e9ea9da4458a |
Source: DailyMed (Structured Product Labeling) · 2026-06-15 · not reviewed by a clinician
Source: National Library of Medicine (DailyMed). Label text as approved by the US Food and Drug Administration. Reuse terms: US government work (NLM).
Other strengths and forms
13 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated6 products
- Tablet, Coated2 products
500 mg2
500 mg · 2 companies
- tablet, film coated1 products
- 500 mg
- Suspension1 products
Show all forms · 7 forms
- Powder1 products
- Capsule, Liquid Filled1 products
- Tablet1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.