Active Ingredients (in each tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

for the temporary relief of minor aches and pains due to:

Headache
Muscular aches
Backache
Minor pain of arthritis
The common cold
Toothache
premenstrual and menstrual cramps

Temporarily reduces fever

Warnings

Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets 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 non prescription). 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 appear
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 the 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 the directed

adults and children 12 years and over:

take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 8 tablets in 24 hours
Do not take for more than 10 days unless directed by a doctor

children under 12 years: do not use Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

Do not use if imprinted safety seal under cap is broken or missing.
store at room temperature

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

Adverse Drug Events call (800) 616-2471

Principal Display Panel of Extra Strength Mapap 500 mg

NDC 0904-1988-60

MAJOR

See New Warning Information

Extra Strength
Mapap

TABLETS

ASPIRIN FREE
STRONG PAIN &
FEVER RELIEF

Compare to active ingredient in Extra Strength Tylenol® *

*this product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.

100 ACETAMINOPHEN TABLETS
500 MG EACH

Extra Strength Mapap 500 mg 100 ct label

EXTRA STRENGTH MAPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0904-1988
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
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (round flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0904-1988-80	1000 TABLET In 1 BOTTLE, PLASTIC	None
2	0904-1988-60	100 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/04/2011

Labeler - Major Pharmaceuticals (191427277)

Revised: 05/2011Major Pharmaceuticals