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 8 caplets in 24 hours, which is the maximum daily amount
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.

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.

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 Liver warning)

adults and children 12 years and over	take 2 caplets every 6 hours while symptoms last do not take more than 8 caplets in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, starch, stearic acid *may contain one or more of these ingredients

Questions or comments?

1-800-719-9260

Principal Display Panel

Extra Strength

See New Warnings Information

Pain Relief

Pain Reliever/Fever Reducer

Acetaminophen

Contains no aspirin

Caplets

500 mg each

Compare to active ingredient of Tylenol® Caplets

Pain Relief Caplets Carton Image #1

Pain Relief Caplets Carton Image #2

GOOD SENSE PAIN RELIEF
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0113-0484
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
CROSCARMELLOSE SODIUM
HYPROMELLOSES
POLYETHYLENE GLYCOL
POVIDONE
SODIUM METABISULFITE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (caplet)	Size	16mm
Flavor		Imprint Code	L484
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0113-0484-52	10 TABLET In 1 VIAL	None
2	0113-0484-62	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		24 TABLET In 1 BOTTLE	This package is contained within the CARTON (0113-0484-62)
3	0113-0484-71	1 BOTTLE In 1 CARTON	contains a BOTTLE
3		50 TABLET In 1 BOTTLE	This package is contained within the CARTON (0113-0484-71)
4	0113-0484-78	1 BOTTLE In 1 CARTON	contains a BOTTLE
4		100 TABLET In 1 BOTTLE	This package is contained within the CARTON (0113-0484-78)
5	0113-0484-82	2 BOTTLE In 1 CARTON	contains a BOTTLE
5		100 TABLET In 1 BOTTLE	This package is contained within the CARTON (0113-0484-82)
6	0113-0484-76	1 BOTTLE In 1 CARTON	contains a BOTTLE
6		120 TABLET In 1 BOTTLE	This package is contained within the CARTON (0113-0484-76)
7	0113-0484-90	500 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/15/1989

Labeler - L Perrigo Company (006013346)

Revised: 05/2009L Perrigo Company