TYLENOL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated 
Lil' Drug Store Products, 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 ® Acetaminophen 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 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide


1
contains one or more of these ingredients

Questions or comments?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

Repackaged and distributed by Convenience Valet ®, Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

TYLENOL 2TYLENOL®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

2 Pouches of

2 Caplets each

500mg each

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

TYLENOL®

FOR ADULTS
Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

3 Pouches of
2 Caplets each
500 mg each

Tylenol 03

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

30 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is opened

30 Pouches of 2 Caplets each - 500 mg each

TYLENOL 30 BOX

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

25 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is opened

25 Pouches of 2 Caplets each - 500 mg each

Tylenol 25

Tylenol ES CVP 4 Count Carton

TYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

EXTRA STRENGTH

500 mg each

4
Caplets

2 POUCHES OF 2 CAPLETS EACH

CVP

HEALTH

Tylenol ES CVP 4ct

TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6547
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6547-44 in 1 CARTON08/25/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01308/25/2017
TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-7025-225 in 1 BOX07/21/2020
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01308/19/1984
TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1887
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-1887-42 in 1 PACKAGE08/19/198405/06/2025
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01308/19/198405/06/2025
TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-7003-230 in 1 BOX08/19/1984
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01308/19/1984
TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6926
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6926-33 in 1 PACKAGE08/19/198411/07/2025
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01308/19/198411/07/2025
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 7/2023
Document Id: 00c881a1-2ca9-a9c0-e063-6294a90a3e0a
Set id: 68bb463c-91af-4eca-b2d5-9d134a756a45
Version: 15
Effective Time: 20230718
 
Lil' Drug Store Products, Inc.