EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [DIRECT RX]

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [DIRECT RX]
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NDC 61919-271-50
Set ID 676061c0-af5e-2be9-e053-2991aa0a2445
Category HUMAN OTC DRUG LABEL
Packager DIRECT RX
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Acetaminophen 500 mg

  • PURPOSE

    Pain Reliever/Fever Reducer

  • WHEN USING

    temporarily relieves minor aches and pains
    temporarily reduces fever

  • WARNINGS

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    more than 8 tablets 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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 symptom 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.

    Overdose Warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Keep out of reach of children.

  • WHEN USING

    do not take more than directed
    adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
    children under 12 years: do not use

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    store at 20⁰C-25⁰C (68⁰F-77⁰F)
    for institutional use only

  • INACTIVE INGREDIENT

    povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    271

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-271(NDC:57896-201)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-271-5050 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/14/2018
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-271)

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