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TYLENOL Extra Strength by Cardinal Health

Medically reviewed on June 21, 2018

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

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.

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.

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 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 www.tylenol.com 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

Acetaminophen

Extra Strength

FOR ADULTS

10 Caplets

TYLENOL  EXTRA STRENGTH
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 
HYPROMELLOSE, UNSPECIFIED 
magnesium stearate 
POLYETHYLENE GLYCOL, UNSPECIFIED 
powdered cellulose 
propylene glycol 
shellac 
Sodium Starch Glycolate Type A Potato 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeTYLENOL;500;HOSPITAL
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1929-010 POUCH in 1 BAG
11 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/19/199409/30/2018
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-1929)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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