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

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Tylenol ®

Regular Strength

Drug Facts

Active ingredient (in each capsule)

Acetaminophen 325 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. The maximum daily dose of this product is 10 capsules (3,250 mg) in 24 hours for adults or 5 capsules (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 4 to 6 hours while symptoms last
  • do not take more than 10 capsules in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • take 1 capsule every 4 to 6 hours while symptoms last
  • do not take more than 5 capsules in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information

  • each capsule contains: potassium 25 mg
  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is opened or if foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

ascorbyl palmitate, caprylic/capric triglycerides, dl-α-tocopherol, FD&C red no. 40, gelatin, glycerin, lecithin, medium chain triglycerides, mono-diglycerides, oleic acid, phosphatidylcholines (soya), polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-487-20

TYLENOL®

Actual Size

Acetaminophen

Pain Reliever
Fever Reducer

Regular Strength

Liquid Gels

*Liquid-Filled Capsules

20 Liquid Gels*
325 mg each

PRINCIPAL DISPLAY PANEL
TYLENOL  REGULAR STRENGTH
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-487
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POTASSIUM ACETATE (UNII: M911911U02)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize22mm
FlavorImprint Code TY;325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-487-201 in 1 CARTON01/05/201601/31/2025
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-487-901 in 1 CARTON01/05/201611/30/2024
290 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/05/201601/31/2025
Labeler - Kenvue Brands LLC (118772437)

Revised: 11/2024
 
Kenvue Brands LLC