MAPAP- acetaminophen tablet
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 Regular Strength (Acetaminophen 325 mg) Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 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

adult takes more than 4,000 mg in 24 hours
child takes more than 5 doses in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 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 the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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 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)

AGE	DOSE
Adults and children 12 years and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
Children 6 years to under 12 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
Children under 6 years	ask a doctor

Other information

Store at room temperature

Inactive ingredients

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 0904-1982-60

Mapap

Regular Strength

TABLETS

Aspirin–Free Pain Reliever/Fever Reducer

See New Warnings Information & Directions

100 ACETAMINOPHEN TABLETS

325 mg EACH

Major 1982 - APAP 325 mg Tabs

NDC 0904-1982-61

Unit Dose

0904-1982-61

MAPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-1982
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE K12 (UNII: 333AG72FWJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-1982-59	1 in 1 BOX	04/21/2011	03/31/2021
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0904-1982-61	100 in 1 CARTON	04/21/2011	10/31/2019
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0904-1982-51	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	06/30/2021
4	NDC:0904-1982-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	07/31/2021
5	NDC:0904-1982-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	09/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	04/21/2011	09/30/2021

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2019

Document Id: 994f5b8a-504c-df25-e053-2995a90a3f29

Set id: 9909dcd1-116d-4ed7-b9a6-ff2074e32f64

Version: 20

Effective Time: 20191209

Major Pharmaceuticals