Label: ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet

  • NDC Code(s): 69168-010-30, 69168-010-50, 69168-010-60
  • Packager: Allegiant Health
  • DEA Schedule: None

Drug Label Information

Updated January 7, 2019

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

  • Active Ingredient (in each tablet)

    Acetaminophen 325mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with:

    • headache
    • backache
    • muscular aches
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours

    for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

    • adult takes more than 4,000mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • 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 non-prescription). 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 user has

    liver disease.

    Ask a doctor or pharmacist before use if

    • the user is taking the blood thinning drug warfarin
    • is a child with pain of arthritis

    Stop use and ask a doctor if

    • Adult’s pain gets worse or lasts more than 10 days
    • Child’s pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

    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 (1-800-222-1222) right away.
    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, unless directed by a doctor
    • Do not use for more than 10 days unless directed by a doctor

    Children 6-11 years of age:

    • 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

  • Other information

    • store at room temperature 20°– 25°C (68°– 77°F)
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or Comments

    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Pain Relief

    Pain Relief

    Pain Relief

    Pain Relief

    acetaminophen 325mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Inactive Ingredients
    Ingredient NameStrength
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (Round Circle) Size11mm
    FlavorImprint Code AZ;010
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-010-601 in 1 CARTON04/15/2016
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69168-010-501 in 1 CARTON04/15/2016
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69168-010-301 in 1 CARTON12/15/2021
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/15/2016
    Labeler - Allegiant Health (079501930)