MAPAP EXTRA STRENGTH- acetaminophen capsule 
State of Florida DOH Central Pharmacy

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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Extra Strength APAP Capsules

Drug Facts

Active Ingredient

(in each capsule)
Acetaminophen 500 mg

Purposes

Analgesic, Antipyretic

Uses

Warnings

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

Do not use

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

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

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 Capsules

 

MAPAP  EXTRA STRENGTH
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0822(NDC:0904-1987)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code CPC;617
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53808-0822-130 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/FEIBusiness Operations
State of Florida DOH Central Pharmacy829348114repack(53808-0822)

Revised: 8/2013
Document Id: 41c99d5e-a695-4aba-8131-6104068368c5
Set id: 02f8cd87-ba7c-4314-9475-8a5b72c60545
Version: 1
Effective Time: 20130808
 
State of Florida DOH Central Pharmacy