MAPAP EXTRA STRENGTH- acetaminophen capsule

MAPAP by

Drug Labeling and Warnings

MAPAP by is a Otc medication manufactured, distributed, or labeled by State of Florida DOH Central Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

(in each capsule)
Acetaminophen 500 mg

Purposes

Analgesic, Antipyretic

Uses

• temporarily relieves minor aches and pains due to
• the common cold
• headache
• toothache
• muscular aches
• backache
• minor pain of arthritis
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 capsules in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drugs 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 you have

liver disease

Ask a doctor before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts more than 3 days

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 In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and over: take 2 capsules every 4 hour to 6 hours, not to exceed 8 capsules in 24 hours. Do not take for more than 10 days unless directed by a doctor.
• children under 12 years of age: Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause liver damage.

DO NOT EXCEED RECOMMENDED DOSE

Other information

• store at room temperature, USP
• use by expiration date on pckage
• do not use if capsule band or imprinted safety seal under cap is broken or missing
• side effects occur
• You may report side effects at 1-800-616-2471 (Toll Free)

Inactive Ingredients

FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

*Major Extra Strength Mapap is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

Distributed by:
MAJOR PHARMACEUTICALS
Livonia, MI 48150  USA

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0822-1	500 mg	30 Capsules in a Blister Pack	RED	0904-1987

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

MAPAP  EXTRA STRENGTH
acetaminophen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53808-0822(NDC:0904-1987)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	CPC;617
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53808-0822-1	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/01/2013

Labeler - State of Florida DOH Central Pharmacy (829348114)

Establishment
Name	Address	ID/FEI	Business Operations
State of Florida DOH Central Pharmacy		829348114	repack(53808-0822)