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 Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)

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 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 directed (see overdose warning)
  

adults and children 12 years and over:

• take 2 caplets every 4 to 6 hours while symptoms last
• do not take more than 6 caplets 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 Hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

QUESTIONS

Questions or comments? Call (800) 616-2471

OTHER SAFETY INFORMATION

Do not use if imprinted safety seal under cap is broken or missing

SPL UNCLASSIFIED SECTION

Distributed By: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC: 0904-1983-60

See New Warnings Information and Directions

EXTRA STRENGTH

Mapap®

ASPIRIN FREE

ACETAMINOPHEN CAPLETS

STRONG PAIN & FEVER RELIEF

100 Caplets

500 mg. Each

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MAPAP 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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, PREGELATINIZED 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: 0904-1983-94	1 in 1 CARTON	05/04/2011	01/31/2020
1		175 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0904-1983-51	1 in 1 CARTON	05/04/2011	05/31/2020
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0904-1983-59	1 in 1 CARTON	05/04/2011	01/31/2020
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 0904-1983-24	1 in 1 CARTON	05/04/2011	01/31/2020
4		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 0904-1983-40	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	01/31/2020
6	NDC: 0904-1983-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	01/31/2020
7	NDC: 0904-1983-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	11/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/04/2011	05/31/2020

Labeler - Major Pharmaceuticals (191427277)