Tylenol

Purpose of Tylenol

Tylenol (generic: acetaminophen) is an over-the-counter medication used to reduce pain due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

Tylenol is also used to temporarily reduce fever.

Active Ingredients

Tylenol (regular strength): Acetaminophen 325 mg

Tylenol Extended Release: Acetaminophen 650 mg

Tylenol Extra Strength: Acetaminophen 500 mg

 

Inactive Ingredients

Tylenol (regular strength): carnauba wax, castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

Tylenol Extended Release: benzyl alcohol, butylparaben, castor oil, corn starch, edetate calcium disodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide

Tylenol Extra Strength: carnauba wax castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

 

Tylenol FDA Warning

Liver warning - Severe liver damage may occur if the following occur:

  • an adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • a child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • an adult has 3 or more alcoholic drinks every day while using this product

Serious skin reaction

  • Symptoms may include skin reddening, rash, blisters, and the upper surface of the skin may become separated from the lower layers.
  • This can occur even if you have taken acetaminophen (Tylenol) in the past without any problems.
  • If you develop any skin rash or reaction while using a medicine containing acetaminophen (Tylenol), stop the medicine and seek medical attention immediately. A health care professional will evaluate you to determine if you are experiencing a serious skin reaction. 
  • If you have had a serious skin reaction with acetaminophen, do not take it or any products containing acetaminophen (Tylenol) again. Doing so could cause you to have another serious skin reaction.
  • Talk to your health care professional if you have any questions or concerns about acetaminophen (Tylenol) or other pain relievers/fever reducers.

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
  • if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets (Tylenol Extended Release)

Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days in adults and children
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 day
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breastfeeding, ask a health professional before use. 

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Tylenol (regular strength):

Adults & Children 12 years and over: 

  • Take 2 caplets every 4 to 6 hours while symptoms last.
  • Do not take more than 12 caplets in 24 hours.
  • Do not use for more than 10 days unless directed by a doctor.

Tylenol Extended Release:

Adults (those 18 years and older):

  • Take 2 gelcaps every 8 hours. Swallow only one gelcap at a time.
  • Take a sip of water before swallowing each gelcap and wash each gelcap down with water (up to a full 8 oz glass).
  • Swallow whole – do not crush, chew, split or dissolve.
  • Do not take more than 6 gelcaps in 24 hours.
  • Do not use for more than 10 days unless directed by a doctor.

Tylenol Extra Strength:

For 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.

Pediatric Use

Do not take more than directed.

Tylenol (regular strength):

For children 6-11 years old:

  • Take 1 caplet every 4 to 6 hours while symptoms last.
  • Do not take more than 5 caplets in 24 hours.
  • Do not use for more than 5 days unless directed by a doctor.

For children under 6 years of age, do not use this adult product. This will provide more than the recommended dose (overdose) and may cause liver damage.

Tylenol Extended Release:

Those under 18 years of age, ask a doctor before use.

Tylenol Extra Strength:

For children under 12 years, ask a doctor before use.

Other Information About Tylenol

Tylenol (regular strength):

Store at room temperature between 20-25˚C (68-77˚F).

Tylenol Extended Release:

  • Store at room temperature between 20–25°C (68–77°F). Avoid high humidity.
  • Do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal" is broken.
  • See end panel for lot number and expiration date.

Tylenol Extra Strength:

  • Store at room temperature between 20-25°C (68-77°F).
  • Tamper evident statement.
  • See end panel for lot number and expiration date.