EXTRA STRENGTH MAPAP- acetaminophen tablet

Extra Strength Mapap by

Drug Labeling and Warnings

Extra Strength Mapap by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC: 68788-9394

See New Warnings Information and Directions

EXTRA STRENGTH

Mapap TABLETS

ASPIRIN FREE

STRONG PAIN AND FEVER RELIEF

500 MG EACH

Repackaged By: Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MAPAP 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9394(NDC:0904-1988)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9394-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2014
2	NDC: 68788-9394-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2014
3	NDC: 68788-9394-4	45 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2014
4	NDC: 68788-9394-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2014
5	NDC: 68788-9394-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/24/2014

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-9394)