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TYLENOL Extra Strength by Cardinal Health

Dosage form: tablet, coated
Ingredients: Acetaminophen 500mg
Labeler: Cardinal Health
NDC Code: 55154-1929

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


Pain reliever/fever reducer

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


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

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.

EZ Dose

Clear dosing information for ease of identification

Perforation and rounded cornersfor esy dispensing.

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.

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 years

ask a doctor

Other information
store between 20-25°C (68-77°F)
do not use if any individual blister unit is open or torn

Inactive ingredients

carnauba wax, castor oil*, 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)

Visit us at or call toll-free 1-877-TYLENOL (1-877-895-3665)

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L5220561 0816

Principal Display Panel

Tylenol 500 mg


Extra Strength


10 Caplets

acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1929(NDC:50580-451)
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 
magnesium stearate 
Polyethylene glycols 
powdered cellulose 
propylene glycol 
Sodium Starch Glycolate Type A Potato 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
FlavorImprint CodeTYLENOL;500;HOSPITAL
#Item CodePackage Description
1NDC:55154-1929-010 POUCH in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/19/1994
Labeler - Cardinal Health (188557102)
Cardinal Health188557102REPACK(55154-1929)

Revised: 08/2016
Cardinal Health

← See all TYLENOL Extra Strength brands

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.