MAPAP- acetaminophen tablet 
A-S Medication Solutions

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 ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Aspirin-Free 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 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 or comments?

Adverse Drug Event call (800) 616-2471

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

LHC54731216

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

HOW SUPPLIED

Product: 50090-0266

NDC: 50090-0266-3 30 TABLET in a BOTTLE

NDC: 50090-0266-1 15 TABLET in a BOTTLE

ACETAMINOPHEN

Label Image
MAPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0266(NDC:0904-1982)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K12 (UNII: 333AG72FWJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint Code GPI;A325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0266-3 30 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
2NDC:50090-0266-1 15 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/21/2011
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0266) , REPACK(50090-0266)

Revised: 9/2017
Document Id: 96e41c6d-c8bc-49b6-863b-2f6bb32484f2
Set id: 90284489-a5ee-43eb-882e-a42f5f885401
Version: 4
Effective Time: 20170925
 
A-S Medication Solutions