MAPAP- acetaminophen tablet
Lake Erie Medical DBA Quality Care Products LLC

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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Drug Facts

Active Ingredients (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 12 tablets in 24 hours,which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

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 and children
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: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Do not use

with any other drug containing acetaminophen (prescription or non prescription). 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 and children
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

Taking more than the recommended dose (overdose) may cause liver damage. 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

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 12 tablets in 24 hours
Children 6 to 11 years	Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours
Children under 6 years	Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

Store at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

To Report Adverse Drug Event call (800) 616-2471 Dist. By MAJOR PHARMACEUTICALS 31778 Enterprise Drive. Livonia, MI 48150

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Reorder No. 251706

image description

MAPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49999-131(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 (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (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:49999-131-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	09/30/2021
2	NDC:49999-131-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	06/01/2014
3	NDC:49999-131-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	06/01/2014

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 - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Name	Address	ID/FEI	Business Operations
Establishment
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(49999-131)

Revised: 1/2023

Document Id: 019fb3b2-48d9-4bc9-b358-26c71735739c

Set id: 51c44fdf-9b6f-4ded-b755-d18a7d2dd4dc

Version: 5

Effective Time: 20230110

Lake Erie Medical DBA Quality Care Products LLC