TYLENOL- acetaminophen tablet 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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: the common cold, headache, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, and temporarily reduces fever.

Do not use if pouch is opened

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

Do not use

Stop use and ask a doctor if

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: 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 an 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 12 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 yearsdo not use this adult product in children under 6 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

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.

Storage

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

Other

See New Warnings Information

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

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Tylenol® 325 MG

Acetaminophen

Regular Strength

10 Caplets

Bag Label
TYLENOL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-1918(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 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code TYLENOL;325;HOSPITAL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1918-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-1918)

Revised: 9/2013
Document Id: dcd513e5-78f3-4e80-86bd-3ff26cfc7371
Set id: 118de851-8c4e-4080-8218-310493286a11
Version: 3
Effective Time: 20130924
 
Cardinal Health