Label: EXTRA STRENGTH MAPAP- acetaminophen tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 31, 2012

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  • Active Ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    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 you take

    • more than 8 caplets 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 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 you have

    liver disease

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • Pain gets worse or lasts more than 10 days
    • 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 the 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

    Adults and children 12 years and over:

    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • Do not take for more than 10 days unless directed by a doctor

    Children under 12 years: do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

  • Other information

    • Do not use if imprinted safety seal under cap is broken or missing.
    • store at room temperature
  • Inactive ingredients

    Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

  • Questions?

    Adverse Drug Events call (800) 616-2471

    Repacked by:

    H.J. Harkins Company, Inc.

    513 Sandydale Drive

    Nipomo, CA 93444

  • Principal Display Panel of Extra Strength Mapap 500 mg Caplets

    NDC 0904-1983-60

    MAJOR®
    See New Warnings Information
    Extra Strength
    Mapap

    ASPIRIN FREE
    ACETAMINOPHEN

    STRONG PAIN &
    FEVER RELIEF

    CAPLETS

    Compare to active ingredient in Extra Strength Tylenol® Caplets*

    *This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.

    100 Caplets
    500 mg. Each
    NDC 0904-1983-24

    MAJOR®

    EXTRA STRENGTH
    Mapap
    See New Warnings Information
    ASPIRIN FREE
    ACETAMINOPHEN

    STRONG PAIN & FEVER RELIEF

    CAPLETS

    Compare to the active ingredients in Extra Strength Tylenol® Caplets*

    See New Warning Information

    24 Caplets
    500 mg. Each

    Repacked by:

    H.J. Harkins Company, Inc.

    Nipomo, CA 93444

    *This product is not manufactured or distributed by McNeil Consumer Products Co., owner of registered trademark Tylenol®
    Extra Strength Mapap 500 mg caplets 24 ct boxed product label
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH MAPAP  
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-338(NDC:0904-1983)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Biconvex) Size17mm
    FlavorImprint Code GPI;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-338-00100 in 1 BOTTLE
    2NDC:52959-338-1010 in 1 BOTTLE
    3NDC:52959-338-1212 in 1 BOTTLE
    4NDC:52959-338-2020 in 1 BOTTLE
    5NDC:52959-338-2424 in 1 BOTTLE
    6NDC:52959-338-3030 in 1 BOTTLE
    7NDC:52959-338-4040 in 1 BOTTLE
    8NDC:52959-338-5050 in 1 BOTTLE
    9NDC:52959-338-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/04/2011
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack, relabel
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