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

GOOD SENSE PAIN RELIEF (ACETAMINOPHEN) TABLET [L. PERRIGO COMPANY]
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NDC 0113-0403-78
Set ID 8b56bfc0-2253-458d-99a6-0b0f9ae0ba50
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:
    the common cold
    headache
    minor pain of arthritis
    backache
    muscular aches
    toothache
    premenstrual and menstrual cramps
    temporarily reduces fever
  • Warnings

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

    adult takes more than 4,000 mg of acetaminophen in 24 hours
    child takes more than 5 doses in 24 hours
    taken with other drugs containing acetaminophen
    adult has 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 the user has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if the user

    has liver disease
    is a child with pain of arthritis

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    new symptoms occur
    pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
    fever gets worse or lasts for more than 3 days
    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 tablets every 4 to 6 hours while symptoms last
    do not take more than 10 tablets in 24 hours
    do not use for more than 10 days unless directed by a doctor

    children

    6-11 years

    take 1 tablet every 4 to 6 hours while symptoms last
    do not take more than 5 tablets in 24 hours
    do not use for more than 5 days unless directed by a
     
    doctor

    children under

    6 years

    ask a doctor

  • Inactive ingredients

    croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Regular Strength

    Pain Relief TABLETS

    Pain Reliever/Fever Reducer

    Acetaminophen

    Compare to active ingredient of Tylenol® Tablets

    100% SATISFACTION GUARANTEED

    100 Tablets - 325 mg Each

    pain relief image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (beveled edge) Size10mm
    FlavorImprint Code 325MG;L403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0403-781 in 1 CARTON08/15/1989
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/15/1989
    Labeler - L. Perrigo Company (006013346)

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