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Tylenol

Medically reviewed on January 12, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cardinal Health
NDC Code: 55154-1928

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® 325 mg

Active ingredient

Acetaminophen Regular Strength

Drug Facts

Active Ingredient

(in each caplet) Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

Uses

For Hospital and Government Use Only

Temporarily relieves minor aches and pains

due to:

- headache – muscular aches – backache - minor pain of arthritis

- the common cold, -toothache - premenstrual and menstrual cramps

- temporarily reduces fever.

-do not use if any individual blister unit is open or torn

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.

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

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.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking blood thinning drug warfarin.

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

Directions do not take more than directed (see overdose warning)

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
do not use for more than 10 days unless directed by a doctor

children 6-11 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 years

ask a doctor

Inactive ingredients

Carnauba wax, castor oil*, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

*may contain castor oil

Storage

Store between 20-25 C (68-77 F)

Other
EZ DOSE
Clear dosing information for ease of identification
Perforation and rounded corners for easy dispensing

Distributed by:

McNeil Consumer Healthcare

DIVISION OF MCNEIL - PPC, INC.

FORT WASHINGTON, PA 19034 USA

visit us at www.tylenol.com or call toll-free

1-877-TYLENOL (1-877-895-3665)

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

TYLENOL and EZ DOSE are trademarks owned by their respective owners.

Repackaged by Cardinal Health

Zanesville, OH 43701

L5054440-11015

L5054440-21015

Principal Display Panel

Tylenol 325 MG

Acetaminophen

Regular Strength

10 Caplets

TYLENOL 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1928(NDC:50580-501)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CASTOR OIL 
STARCH, CORN 
FD&C RED NO. 40 
ALUMINUM OXIDE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint CodeTYLENOL;325;HOSPITAL
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1928-010 BLISTER PACK in 1 BAG
11 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/06/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-1928)

 
Cardinal Health

Further information

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

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