RUGBY ACETAMINOPHEN (ACETAMINOPHEN) TABLET [RUGBY LABORATORIES]

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RUGBY ACETAMINOPHEN (ACETAMINOPHEN) TABLET [RUGBY LABORATORIES]
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NDC 0536-1164-01
Set ID 7d71d000-d68f-41e0-a746-c5fe9114d160
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 325 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

    •
    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

    •
    pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
    •
    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 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?

    1-800-645-2158

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOL®

    REGULAR STRENGTH

    Acetaminophen

    WITHOUT ASPIRIN

    PAIN RELIEVER/FEVER REDUCER

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    100 Acetaminophen

    Tablets 325 mg Each

    4038T-acetaminophen.jpg
  • INGREDIENTS AND APPEARANCE
    RUGBY ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1164
    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 (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:0536-1164-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/16/2019
    Labeler - Rugby Laboratories (079246066)
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