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

Dosage form: tablet, film coated
Ingredients: Acetaminophen 500mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-378

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 caplet)

Acetaminophen 500 mg

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)
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 yearsask a doctor

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

Inactive ingredients

carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-378-02

TYLENOL®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

Extra Strength

Actual Size

100 Caplets
500 mg each

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-378
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
crospovidone (15 MPA.S AT 5%) 
FD&C red no. 40 
aluminum oxide 
hypromellose, unspecified 
magnesium stearate 
microcrystalline cellulose 
polyethylene glycol, unspecified 
polysorbate 80 
povidone, unspecified 
propylene glycol 
shellac 
sodium starch glycolate type A potato 
stearic acid 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeTYLENOL;500
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-378-011 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:50580-378-021 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:50580-378-03225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2014
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2017
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

← See all Tylenol Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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