TYLENOL EXTRA STRENGTH- acetaminophen tablet, coated 
Johnson & Johnson Consumer Inc.

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.

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TYLENOL

Extra strength

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

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 50580-488-24

Extra Strength
TYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

RAPID RELEASE
GELS

Actual Size

24 Gelcaps*
500 mg each

*Gelatin-Coated Tablets

Principal Display Panel
TYLENOL  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-488
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Colorblue, gray, redScoreno score
ShapeOVALSize21mm
FlavorImprint Code TY;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-488-101 in 1 CARTON01/16/2017
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50580-488-241 in 1 CARTON01/16/2017
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:50580-488-251 in 1 CARTON01/16/2017
3225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:50580-488-28290 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/16/2017
5NDC:50580-488-0150 in 1 TRAY04/17/201712/31/2018
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC:50580-488-521 in 1 CARTON06/17/2019
650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/16/2017
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 3/2023
Document Id: f78204b2-f3c3-a536-e053-6294a90ac35e
Set id: 1b164780-ec84-4187-8afa-6f8a0da550fc
Version: 14
Effective Time: 20230322
 
Johnson & Johnson Consumer Inc.