Tylenol

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cardinal Health
NDC Code: 55154-1918

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.

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:

  • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
  • 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: 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

TYLENOL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeTYLENOL;325;HOSPITAL
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1918-010 BLISTER PACK in 1 BAG
11 TABLET 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/FEIOperations
Cardinal Health188557102REPACK(55154-1918)

Revised: 09/2013
 
Cardinal Health

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.

Hide
(web4)