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

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TYLENOL Regular Strength

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (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 caplets every 4 to 6 hours while symptoms last
  • do not take more than 10 caplets 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 caplet every 4 to 6 hours while symptoms last
  • do not take more than 5 caplets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information

Inactive ingredients

carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

325mg

NDC 50580-458-11
To re-order reference the NDC Code

TYLENOL ®

Acetaminophen Pain Reliever - Fever Reducer

Regular Strength

100 Caplets
325 mg each

10 Blister Cards
with
10 Individual Blisters

SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS

FOR HOSPITAL AND GOVERNMENT USE ONLY

Principal Display Panel
TYLENOL  REGULAR STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-458
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
Colorwhite (White with red print) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Tylenol;325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-458-1110 in 1 CARTON07/17/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-458-501 in 1 CARTON07/17/2020
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:50580-458-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/17/2020
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0e6df648-71b5-61bf-e063-6394a90a0e7f
Set id: 01f41fae-4abb-4b96-ab09-a7d3dfc286cd
Version: 6
Effective Time: 20240108
 
Johnson & Johnson Consumer Inc.