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MAPAP Extra Strength by State of Florida DOH Central Pharmacy

Medically reviewed on August 8, 2018

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg
Labeler: State of Florida DOH Central Pharmacy
NDC Code: 53808-0822

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.

Extra Strength APAP Capsules

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.

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:

NDCStrengthQuantity/FormColorSource Prod. Code
53808-0822-1500 mg30 Capsules in a Blister PackRED0904-1987

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

MAPAP  EXTRA STRENGTH
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0822(NDC:0904-1987)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
POVIDONE K30 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeCPC;617
Contains    
Packaging
#Item CodePackage Description
1NDC:53808-0822-130 CAPSULE (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/2013
Labeler - State of Florida DOH Central Pharmacy (829348114)
Establishment
NameAddressID/FEIOperations
State of Florida DOH Central Pharmacy829348114repack(53808-0822)

 
State of Florida DOH Central Pharmacy

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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