TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

TYLENOL Extra Strength by

Drug Labeling and Warnings

TYLENOL Extra Strength by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. 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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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

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 children12 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)
• do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

carnauba wax1, corn starch1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch1, polyethylene glycol1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

1 contains one or more of these ingredients

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-449-96

TYLENOL®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

Extra Strength
Actual Size

50 Caplets
500 mg each

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-449
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
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	19mm
Flavor		Imprint Code	TYLENOL;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-449-00	1 in 1 CARTON	08/19/1984
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 50580-449-05	1 in 1 CARTON	08/19/1984
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 50580-449-08	2 in 1 POUCH; Type 0: Not a Combination Product	08/19/1984
4	NDC: 50580-449-09	1 in 1 CARTON	08/19/1984
4		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 50580-449-10	50 in 1 TRAY	08/19/1984
5	NDC: 50580-449-08	2 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 50580-449-11	50 in 1 TRAY	08/19/1984
6	NDC: 50580-449-08	2 in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 50580-449-13	3 in 1 CARTON	08/19/1984
7	NDC: 50580-449-08	2 in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 50580-449-14	2 in 1 POUCH; Type 0: Not a Combination Product	08/19/1984
9	NDC: 50580-449-15	10 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product	08/19/1984
10	NDC: 50580-449-23	1 in 1 CARTON	08/19/1984
10		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11	NDC: 50580-449-31	1 in 1 CARTON	08/19/1984
11		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12	NDC: 50580-449-34	325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/1984
13	NDC: 50580-449-35	1 in 1 CARTON	08/19/1984
13		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14	NDC: 50580-449-36	1 in 1 CARTON	08/19/1984
14		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
15	NDC: 50580-449-61	1 in 1 CARTON	08/19/1984
15		225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
16	NDC: 50580-449-62	325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/1984
17	NDC: 50580-449-84	2 in 1 POUCH; Type 0: Not a Combination Product	08/19/1984
18	NDC: 50580-449-85	50 in 1 TRAY	08/19/1984
18	NDC: 50580-449-84	2 in 1 POUCH; Type 0: Not a Combination Product
19	NDC: 50580-449-86	50 in 1 TRAY	08/19/1984
19	NDC: 50580-449-84	2 in 1 POUCH; Type 0: Not a Combination Product
20	NDC: 50580-449-87	3 in 1 CARTON	08/19/1984
20	NDC: 50580-449-84	2 in 1 POUCH; Type 0: Not a Combination Product
21	NDC: 50580-449-12	12 in 1 PACKAGE	10/21/2014
21		10 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
22	NDC: 50580-449-96	1 in 1 CARTON	06/25/2018
22		50 in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC: 50580-449-97	249 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	01/28/2019
24	NDC: 50580-449-98	110 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	01/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	08/19/1984

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)