MAPAP- acetaminophen tablet

Mapap by

Drug Labeling and Warnings

Mapap by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 325 mg

PURPOSE

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• Store at room temperature
  

INACTIVE INGREDIENT

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

QUESTIONS

Questions or comments?Call (800) 616-2471

OTHER SAFETY INFORMATION

Do not use if imprinted Safety Seal under cap is broken or missing

SPL UNCLASSIFIED SECTION

Distributed By: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

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

NDC: 0904-1982-61

Unit Dose

INGREDIENTS AND APPEARANCE

MAPAP 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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, 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/21/2011	09/30/2021

Labeler - Major Pharmaceuticals (191427277)