Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

View All Sections
  • Drug Facts

  • Active Ingredient (in each Tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    for the temporary relief of minor aches and pains due to:

    Headache

    Muscular aches

    Backache

    Toothache

    Premenstrual and menstrual cramps

    Temporally reduces fever.

  • • Liver warning Warnings

    this product contains Acetaminophen. Severe liver damage may occur if

    • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
    • 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
  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription) 
    • 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 the user has

    liver disease

  • 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 in adults.

    Pain gets worse or lasts more than 5 days in children under under 12 years

    Fever gets worse or last 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 doctor before use.

    Keep out of the reach of children.

    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 syptoms.

    • Do not take more tahn directed (see overdose warning)
  • Directions

    Directions 

     Adults and Children

    12 years and older

    Take 2 tablets every 4 to 6 hours while symptoms last

    Do not take more than 12 tablets in 24 hours

    Children

    6 to 11 years

    Take 1 tablet every 4 to 6 hours while symptoms last

    Do not take more than 5 tablets in 24 hours

    Children under

    6 years     

    		Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. 

  • Other information

    store at room temperature 20°-25°C (68-77°F)

  • Inactive Ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

  • Acetaminophen 100 tablet

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-692(NDC:0536-1327)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PH020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-692-10325 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/01/2019
    Labeler - Southern Sales & Service, Inc. (013114906)
    Registrant - Southern Sales & Service, Inc. (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Service, Inc.013114906repack(69822-692)
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!