Label: ACETAMINOPHEN tablet

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

Drug Label Information

Updated August 5, 2025

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

  • Active Ingredient

    Acetaminophen USP, 325mg (in each tablet)

  • Purpose

    Pain Releiver / Fever Reducer

  • 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.

  • Uses

    Temporarily relieves minor aches and pains due to

    Common cold

    headache

    minor pain of arthritis

    toothache

    muscular aches

    premenstrual and menstrual cramps

    temporarily relieves 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:

    • adutls take more than 4000mg 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 ad seek medical medical help right away

  • 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.

  • 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 older

    • 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 years to under 12 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 of age:

    • Ask a doctor

  • 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 a sign of a serious condition

  • If pregnant or breast-feeding

    Ask a health professional before use

  • 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 cretical for adults as well as children even if you do not notice symptoms.

  • Other Information

    • Store at 20ºC - 25ºC (68ºF - 77ºF)
  • Inactive Ingredients

    hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycoate, Stearic Acid

  • Questions or Comments?

    Call 1-888-900-2920

  • Distributed By:

    Distributed By:

    ProStat First Aid

    La Verne, CA. 91750 USA

    *This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

    Made in the USA

  • Label

    HONEYWELL NON-ASPIRIN ACETAMINOPHEN TABLET 325MG 022125 CDER

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-0061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G323
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-0061-110000 in 1 BAG08/06/2025
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/06/2025
    Labeler - Prostat First Aid (061263699)