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 Select Corporation. 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 children 12 years and over
  children under 12 years

• 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)
• do not use if pouch is opened
• see above middle panel for lot number and expiration date

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)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Blister Pack

TYLENOL®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

Extra Strength

2 Caplets
Singple-Pack
500 mg each

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-946(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 (UNII: H8AV0SQX4D)
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: 52904-946-04	1 in 1 BLISTER PACK	03/01/1997
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52904-946-05	2 in 1 BLISTER PACK	03/01/1997
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 52904-946-20	20 in 1 CARTON	03/01/1997
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 52904-946-25	25 in 1 CARTON	03/01/1997
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 52904-946-30	30 in 1 CARTON	03/01/1997
5		2 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 52904-946-50	50 in 1 CARTON	03/01/1997
6		2 in 1 POUCH; 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	03/01/1997

Labeler - Select Corporation (053805599)