MAPAP- acetaminophen tablet

Mapap by

Drug Labeling and Warnings

Mapap by is a Otc medication manufactured, distributed, or labeled by St. Mary's Medical Park Pharmacy, GEMINI PHARMACEUTICALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

MAPAP 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60760-935(NDC:0904-1982)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K12 (UNII: 333AG72FWJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60760-935-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2017

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

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Registrant - GEMINI PHARMACEUTICALS INC. (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
GEMINI PHARMACEUTICALS INC.		055942270	manufacture(60760-935)

Establishment
Name	Address	ID/FEI	Business Operations
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-935) , repack(60760-935)