GOOD SENSE PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [L. PERRIGO COMPANY]

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GOOD SENSE PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [L. PERRIGO COMPANY]
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NDC 0113-0518-83
Set ID 67bdc967-89eb-40ff-ad25-474c8b6472f9
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
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

    •
    temporarily relieves 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 4,000 mg of acetaminophen in 24 hours
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    •
    skin reddening
    •
    blisters
    •
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • Do not use

    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients
  • 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: In 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 (see overdose warning)

    adults and children 12 years and over
    •
    take 2 caplets every 6 hours while symptoms last
    •
    do not take more than 6 caplets in 24 hours, unless directed by a doctor
    •
    do not use for more than 10 days unless directed by a doctor

    children under

    12 years

    ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Extra Strength

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    Pain Relief

    Pain Reliever/Fever Reducer

    Acetaminophen

    Fast Relief - For Adults

    CAPLETS

    Rapid Release

    Compare to active ingredient of Tylenol® Extra Strength

    100% SATISFACTION GUARANTEED

    225 Caplets – 500 mg Each

    pain-relief-image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE PAIN RELIEF 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0518
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 3S0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0518-83225 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/28/2018
    Labeler - L. Perrigo Company (006013346)
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