EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]

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  • EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]

EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]
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NDC 52959-338-00, 52959-338-10, 52959-338-12, 52959-338-20, 52959-338-24, 52959-338-30, 52959-338-40, 52959-338-50, 52959-338-60
Set ID 0eb4c569-08bd-4a37-a0bb-0aadb7294192
Category HUMAN OTC DRUG LABEL
Packager H.J. Harkins Company, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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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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