EXTRA STRENGTH MAPAP- acetaminophen tablet, film coated

Extra Strength Mapap by

Drug Labeling and Warnings

Extra Strength Mapap by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each caplet)

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 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 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 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: 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 directed

Adults and children 12 years and over:

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

Children under 12 years: do not use adult 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

Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

Adverse Drug Events call (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

513 Sandydale Drive

Nipomo, CA 93444

Principal Display Panel of Extra Strength Mapap 500 mg Caplets

NDC: 0904-1983-60

MAJOR®

See New Warnings Information

Extra Strength
Mapap

ASPIRIN FREE
ACETAMINOPHEN

STRONG PAIN &
FEVER RELIEF

CAPLETS

Compare to active ingredient in Extra Strength Tylenol® Caplets*

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

100 Caplets
500 mg. Each
NDC: 0904-1983-24

MAJOR®

EXTRA STRENGTH
Mapap

See New Warnings Information

ASPIRIN FREE
ACETAMINOPHEN

STRONG PAIN & FEVER RELIEF

CAPLETS

Compare to the active ingredients in Extra Strength Tylenol® Caplets*

See New Warning Information

24 Caplets
500 mg. Each

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MAPAP  
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-338(NDC:0904-1983)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Biconvex)	Size	17mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-338-00	100 in 1 BOTTLE
2	NDC: 52959-338-10	10 in 1 BOTTLE
3	NDC: 52959-338-12	12 in 1 BOTTLE
4	NDC: 52959-338-20	20 in 1 BOTTLE
5	NDC: 52959-338-24	24 in 1 BOTTLE
6	NDC: 52959-338-30	30 in 1 BOTTLE
7	NDC: 52959-338-40	40 in 1 BOTTLE
8	NDC: 52959-338-50	50 in 1 BOTTLE
9	NDC: 52959-338-60	60 in 1 BOTTLE

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

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
H.J. Harkins Company, Inc.		147681894	repack, relabel