EXTRA STRENGTH MAPAP- acetaminophen tablet, film coated
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mapap (Acetaminophen) Extra Strength Caplets

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purposes

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 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.

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

Other information

Store at room temperature

Inactive ingredients Hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments? Call (800) 616-2471

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

Distributed By: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

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

Major 1983 - APAP 500 mg Caplets

EXTRA STRENGTH MAPAP
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-1983
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
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/04/2011	05/31/2020

Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2018

Document Id: 72df4170-b616-748f-e053-2991aa0a1ff7

Set id: f40dca66-62c4-4630-aa77-087b297ca7e8

Version: 5

Effective Time: 20180807

Major Pharmaceuticals