TYLENOL EXTRA STRENGTH- acetaminophen tablet, coated
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® 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:

1.: the common cold
2.: headache
3.: backache
4.: minor pain of arthritis
5.: toothache
6.: muscular aches
7.: premenstrual and menstrual cramps

•

temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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.

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 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)
•: tamper evident statement
•: see end panel for lot number and expiration date

Inactive ingredients

carnauba wax1, castor oil2, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol3, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

1: contains one or more of these ingredients
2: contains one or more of these ingredients
3: contains one or more of these ingredients

Questions or comments?

call 1-877-895-3665

Visit us at www.tylenol.com or call toll free 1-877-TYLENOL (1-877-895-3665)

PRINCIPAL DISPLAY PANEL

Tylenol 500mg

Acetaminophen

Extra Strength For Adults

10 Caplets

TYLENOL EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-1909(NDC:50580-451)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Ingredient Name	Strength
Inactive Ingredients
Carnauba wax (UNII: R12CBM0EIZ)
castor oil (UNII: D5340Y2I9G)
starch, corn (UNII: O8232NY3SJ)
FD&C red No. 40 (UNII: WZB9127XOA)
aluminum oxide (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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	OVAL	Size	18mm
Flavor		Imprint Code	TYLENOL;500;HOSPITAL
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-1909-0	10 in 1 BAG	03/06/2013	02/28/2015
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/06/2013	02/28/2015

Labeler - Cardinal Health (188557102)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-1909)

Revised: 12/2017

Document Id: 92ba4c59-873d-410d-806e-09e18b637154

Set id: 937d3bee-2c37-4dac-a79b-2c2b2075db7d

Version: 3

Effective Time: 20171219

Cardinal Health