Extra Strength Mapap (Acetaminophen) Tablet [Major Pharmaceuticals] -

EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]
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NDC	0904-1988-59, 0904-1988-60, 0904-1988-61, 0904-1988-80
Set ID	2a8c94ee-8267-4da0-b90f-2814e8dc1ebd
Generic Name
Product Class
Product Number
Application Number	PART343

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 500 mg
PURPOSE

Purposes

Pain Reliever/Fever Reducer
INDICATIONS & USAGE
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
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 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.
DOSAGE & ADMINISTRATION
Directions
- do not take more than the directed (see overdose warning)
  adults and children 12 years and over:
- take 2 tablets every 6 hours while symptoms last.
- do not take more than 6 tablets in 24 hours unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
STORAGE AND HANDLING
Other information
- Store at room temperature
INACTIVE INGREDIENT

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
QUESTIONS

Questions or comments? Call (800) 616-2471
SPL UNCLASSIFIED SECTION

Distributed By: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA
OTHER SAFETY INFORMATION

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing
PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-1988-60

See New Warnings Information and Directions

EXTRA STRENGTH

Mapap TABLETS

ASPIRIN FREE

STRONG PAIN AND FEVER RELIEF

100 ACETAMINOPHEN TABLETS

500 MG EACH

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MAPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-1988
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
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-1988-61	100 in 1 CARTON	05/04/2011	07/31/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0904-1988-59	1 in 1 CARTON	05/04/2011	06/30/2021
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0904-1988-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	09/30/2021
4	NDC:0904-1988-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	08/24/2021