TYLENOL- acetaminophen tablet 
Cardinal Health

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.

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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:

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 years

do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1918(NDC:50580-501)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CASTOR OIL (UNII: D5340Y2I9G)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code TYLENOL;325;HOSPITAL
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-1918-0 10 in 1 BAG
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/06/2011
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-1918)

Revised: 3/2015
Document Id: 66f6d7a4-a3b1-4e42-adff-8425f701d830
Set id: 118de851-8c4e-4080-8218-310493286a11
Version: 4
Effective Time: 20150310
 
Cardinal Health