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

GOOD SENSE PAIN RELIEF (ACETAMINOPHEN) TABLET [L. PERRIGO COMPANY]
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NDC 0113-0484-02, 0113-0484-52, 0113-0484-62, 0113-0484-71, 0113-0484-76, 0113-0484-78, 0113-0484-82, 0113-0484-90
Set ID 7f78028a-484b-48b3-a37a-1e0b055bbefc
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:
    the common cold
    headache
    backache
    minor pain of arthritis
    toothache
    muscular aches
    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 20-25ºC (68-77ºF)
  • Inactive ingredients

    carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain one or more of these ingredients

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Extra Strength

    See New Warnings

    Pain Relief

    CAPLETS

    Actual Size

    Pain Reliever/Fever Reducer

    Acetaminophen

    For Adults

    Compare to active ingredient of Tylenol® Caplets

    100 Caplets – 500 mg Each

    Good Sense Pain Relief Image 1
    Good Sense Pain Relief Image 2
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0484
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (caplet) Size16mm
    FlavorImprint Code L484
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0484-5210 in 1 VIAL; Type 0: Not a Combination Product09/15/1989
    2NDC:0113-0484-621 in 1 CARTON09/15/1989
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0113-0484-711 in 1 CARTON09/15/1989
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0113-0484-781 in 1 CARTON09/15/1989
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0113-0484-761 in 1 CARTON09/15/1989
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0113-0484-90500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/1989
    7NDC:0113-0484-822 in 1 CARTON09/15/1989
    7100 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0113-0484-02550 in 1 BOTTLE; Type 0: Not a Combination Product09/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/15/1989
    Labeler - L. Perrigo Company (006013346)