Tylenol extra strength coated tablets with acetaminophen 500 mg

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 23, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
  • Active ingredient (in each caplet)
  • Purpose

    Pain reliever/fever reducer

  • 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

    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.

  • Directions

    • do not take more than directed (see overdose warning)

  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

  • Inactive ingredients

    carnauba wax 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide


    1contains one or more of these ingredients

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-449-96

    TYLENOL ®
    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    Extra Strength
    Actual Size

    50 Caplets
    500 mg each

    Tylenol extra strength coated tablets with acetaminophen 500 mg

View Labeling Archives for this drug

TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

Number of versions: 17

Published Date (What is this?)VersionFiles
Aug 25, 2022 17 (current) download
Nov 18, 2021 16 download
Oct 12, 2021 15 download
Jul 22, 2020 14 download
Jul 18, 2019 13 download
May 20, 2019 12 download
Feb 13, 2019 11 download
Jan 28, 2019 10 download
Jan 31, 2018 9 download
Jan 19, 2018 8 download
Dec 21, 2016 7 download
Jul 5, 2016 6 download
Oct 14, 2015 5 download
Oct 22, 2014 4 download
Jun 16, 2014 3 download
Jul 31, 2013 2 download
Dec 1, 2011 1 download

RxNorm

TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

RxCUIRxNorm NAMERxTTY
1 198440 acetaminophen 500 MG Oral Tablet PSN
2 198440 acetaminophen 500 MG Oral Tablet SCD
3 198440 APAP 500 MG Oral Tablet SY
4 209459 Tylenol Extra Strength 500 MG Oral Tablet PSN
5 209459 acetaminophen 500 MG Oral Tablet [Tylenol] SBD
6 209459 APAP 500 MG Oral Tablet [Tylenol] SY
7 209459 Tylenol 500 MG Oral Tablet SY
8 209459 Tylenol Extra Strength 500 MG Oral Tablet SY

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Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

NDC Codes

TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 50580-449-00
2 50580-449-05
3 50580-449-08
4 50580-449-09
5 50580-449-10
6 50580-449-11
7 50580-449-12
8 50580-449-13
9 50580-449-14
10 50580-449-15
11 50580-449-23
12 50580-449-31
13 50580-449-34
14 50580-449-35
15 50580-449-36
16 50580-449-61
17 50580-449-62
18 50580-449-84
19 50580-449-85
20 50580-449-86
21 50580-449-87
22 50580-449-96
23 50580-449-97
24 50580-449-98

What is the difference between coated Tylenol and regular Tylenol?

The main difference between the types of Tylenol is the amount of acetaminophen in each one.

How many 500 mg Extra Strength Tylenol can you take in a day?

Each tablet, capsule, or gelcap contains 500 milligrams (mg) of acetaminophen. Extra Strength Tylenol can be used in adults and children 12 years and over. The recommended dose is two tablets, capsules, or gelcaps every six hours as needed. The maximum daily dose is six tablets, capsules, or gelcaps.

What is Tylenol Extra Strength 500 mg used for?

Containing 500 mg of acetaminophen, TYLENOL® Extra Strength Caplets help temporarily reduce fever in adults and children 12 years and older, and provide powerful relief of tension headaches, minor back and muscle pain, minor arthritis pain and more.

What does it mean when Tylenol is coated?

Enteric-coated pain medication is surrounded by special ingredients that are said to prevent irritation of the stomach lining and usually come in tablet or capsule form.