TYLENOL EXTRA STRENGTH- acetaminophen capsule, liquid filled 
Kenvue Brands LLC

----------

TYLENOL® EXTRA STRENGTH

Drug Facts

Active ingredient (in each capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

​■ the common cold

■ headache

■ backache

■ minor pain of arthritis

■ toothache

■ muscular aches

■ premenstrual and menstrual cramps

Warnings

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 capsules every 6 hours while symptoms last
  • do not take more than 6 capsules in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-469-18

NEW

Extra Strength

TYLENOL ®
FOR ADULTS

Acetaminophen

Pain Reliever - Fever Reducer

LIQUID GELS

Actual Size

18 Liquid Gels*

500 mg each

*Liquid Filled Capsules

tylenol-1

TYLENOL EXTRA STRENGTH 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-469
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize24mm
FlavorImprint Code TY;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-469-181 in 1 CARTON10/27/2025
118 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-469-401 in 1 CARTON10/27/2025
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-469-751 in 1 CARTON10/27/2025
375 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/27/2025
Labeler - Kenvue Brands LLC (118772437)

Revised: 8/2025
Document Id: 3bb7dcea-736b-343c-e063-6394a90a89e0
Set id: 3bb7dc60-97b2-1291-e063-6294a90a26d9
Version: 1
Effective Time: 20250812
 
Kenvue Brands LLC