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TYLENOL EXTRA STRENGTH by Lil' Drug Store Products, Inc.

Medically reviewed on November 20, 2017

Dosage form: tablet, coated
Ingredients: Acetaminophen 500mg
Labeler: Lil' Drug Store Products, Inc.
NDC Code: 66715-9747

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.

TYLENOL® EXTRA STRENGTH

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

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

Taking more than the recommended dose (overdose) may cause liver damage. 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
  • do not take more than directed (see overdose warning)
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
  • store between 20-25°C (68-77°F)
  • do not use if carton or pouch is open
  • see bottom panel for lot number and expiration date

Inactive ingredients

carnauba wax, castor oil1, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide


contains one or more of these ingredients

Questions or comments?

call 1-877-895-3665

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Carton

See New Warnings Information & Directions
TYLENOL®

Pain Reliever
Fever Reducer
Acetaminophen

EXTRA
STRENGTH

For Adults

Caplets

2 CAPLETS
500 mg each

Lil'
Drug Store®

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9747(NDC:50580-449)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
castor oil 
starch, corn 
FD&C red no. 40 
aluminum oxide 
hypromelloses 
magnesium stearate 
polyethylene glycols 
powdered cellulose 
propylene glycol 
shellac 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeTYLENOL;500
Contains    
Packaging
#Item CodePackage Description
1NDC:66715-9747-11 POUCH in 1 CARTON
12 TABLET, COATED in 1 POUCH
2NDC:66715-9747-22 POUCH in 1 CARTON
22 TABLET, COATED in 1 POUCH
3NDC:66715-9747-33 POUCH in 1 CARTON
32 TABLET, COATED in 1 POUCH
4NDC:66715-9747-730 POUCH in 1 CARTON
42 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/09/2011
Labeler - Lil' Drug Store Products, Inc. (093103646)

 
Lil' Drug Store Products, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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