Label: LEADER ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 70000-0374-1
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 17, 2021

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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?

    1-800-719-9260

  • Principal Display Panel

    Regular Strength

    Acetaminophen Tablets, 325 mg

    Pain Reliever / Fever Reducer

    Aspirin Free

    COMPARE TO REGULAR STRENGTH TYLENOL® TABLETS active ingredient

    Actual Size

    100 TABLETS

    100% Money Back Guarantee

    403-e9-acetaminophen.jpg
  • INGREDIENTS AND APPEARANCE
    LEADER ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0374
    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:70000-0374-11 in 1 CARTON08/22/2018
    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 finalpart34308/22/2018
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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