Label: ACETAMINOPHEN tablet

  • NDC Code(s): 41415-177-05, 41415-177-10, 41415-177-25
  • Packager: PUBLIX SUPERMARKETS, INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 18, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient (in each caplet)

    Acetaminophen USP, 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 are allergic to acetaminophen or any of the inactive ingredients in this product

  • 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

    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 between 20-25°C (68-77°F). See USP Controlled Room Temperature.
    ■ see end panel for lot number and expiration date

  • Inactive ingredients

    hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • Principal display panel

    50ct100ct250ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-177
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G;551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-177-0550 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2024
    2NDC:41415-177-10100 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2024
    3NDC:41415-177-25250 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/02/2024
    Labeler - PUBLIX SUPERMARKETS, INC (006922009)
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

More Info on this Drug

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