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

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Tylenol ® Extra Strength

Drug Facts

Active ingredient (in each caplet)

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 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

Inactive ingredients

carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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 50580-378-06

TYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

Extra Strength

Actual Size

100 Caplets
500 mg each

PRINCIPAL DISPLAY PANEL
TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-378
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-378-011 in 1 CARTON11/01/2014
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50580-378-021 in 1 CARTON11/01/2014
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:50580-378-03225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2015
4NDC:50580-378-041 in 1 CARTON03/01/2021
424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:50580-378-051 in 1 CARTON03/01/2021
550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:50580-378-061 in 1 CARTON03/01/2021
6100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:50580-378-071 in 1 CARTON03/01/2021
7225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:50580-378-08325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/01/2014
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0e8507e0-bb22-2ab4-e063-6294a90a1f8f
Set id: 17cfa99d-abb2-4d77-9e0e-e77109fbb61a
Version: 12
Effective Time: 20240109
 
Johnson & Johnson Consumer Inc.