TYLENOL EXTRA STRENGTH- acetaminophen tablet, coated

TYLENOL EXTRA STRENGTH by

Drug Labeling and Warnings

TYLENOL EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, 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 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 carton or pouch is torn or damaged
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

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

SPL UNCLASSIFIED SECTION

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Carton

TYLENOL®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

EXTRA STRENGTH

500 mg each

6
Caplets

Lil'
Drug Store®

Principal Display Panel - 500 mg Caplet Pouch Carton

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9747
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)
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)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	TYLENOL;500
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 66715-9747-1	1 in 1 CARTON	04/16/2018
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9747-2	2 in 1 CARTON	04/13/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 66715-9747-3	3 in 1 CARTON	06/29/2018
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 66715-9747-7	30 in 1 CARTON	04/09/2018
4		2 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	08/09/2011

Labeler - Lil' Drug Store Products, Inc. (093103646)