Label: PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 0363-0484-52, 0363-0484-62, 0363-0484-71, 0363-0484-78, view more
    0363-0484-83, 0363-0484-90
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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
    •
    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 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

    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    Compare to the active ingredient in Extra Strength Tylenol® Caplets

    FOR ADULTS

    Pain Reliever

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

    Extra Strength

    100 CAPLETS 500 mg EACH

    ACTUAL SIZE

    pain reliever-image
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0484
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code L484
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0484-5210 in 1 VIAL; Type 0: Not a Combination Product01/21/200905/21/2013
    2NDC:0363-0484-621 in 1 CARTON03/30/2022
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0484-711 in 1 CARTON03/30/2022
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0484-781 in 1 CARTON03/30/2022
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0484-90500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2022
    6NDC:0363-0484-831 in 1 CARTON09/26/2022
    6225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/21/2009
    Labeler - Walgreen Company (008965063)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!