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TYLENOL Extra Strength by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, coated
Ingredients: Acetaminophen 500mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-488

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.

TYLENOL®
Extra strength

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • 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)
adults and children 12 years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

Other information
  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-488-25

Extra Strength
TYLENOL
®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

RAPID RELEASE
GELS

Actual Size

225 Gelcaps*
500 mg each

*Gelatin-Coated Tablets

TYLENOL   EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-488
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
butylparaben 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
D&C yellow no. 10 
edetate calcium disodium 
FD&C blue no. 1 
FD&C red no. 40 
GELATIN, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
magnesium stearate 
methylparaben 
POLYETHYLENE GLYCOL, UNSPECIFIED 
polysorbate 80 
powdered cellulose 
propylene glycol 
propylparaben 
ferric oxide red 
sodium lauryl sulfate 
sodium propionate 
sodium starch glycolate type A potato 
titanium dioxide 
ferric oxide yellow 
Product Characteristics
ColorRED, BLUE, GRAYScoreno score
ShapeOVALSize21mm
FlavorImprint CodeTY;500
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-488-101 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:50580-488-241 BOTTLE, PLASTIC in 1 CARTON
224 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:50580-488-251 BOTTLE, PLASTIC in 1 CARTON
3225 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:50580-488-28290 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:50580-488-0150 POUCH in 1 TRAY
52 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/16/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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