Label: ACETAMINOPHEN 325 MG- acetaminophen tablet

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

Drug Label Information

Updated February 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen USP, 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    headache
    •
    muscular aches
    •
    backache
    •
    minor pain of arthritis
    •
    the common cold
    •
    toothache
    •
    premenstrual or menstrual cramps
    •
    temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    •
    adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
    •
    child takes more than 5 tablets in 24 hours, which is the maximum daily amount
    •
    taken with other drugs containing acetaminophen
    •
    adult has 3 or more alcoholic drinks while using this product
  • OTHER SAFETY INFORMATION

    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

    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.

  • ASK DOCTOR

    Ask a doctor before use if the user has liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

  • STOP USE

    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
    •
    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.

  • PREGNANCY OR BREAST FEEDING

    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: 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 symptoms.

  • Directions

    •
    do not take more than directed (see overdose warning)

    adults and children 12 years and over

    take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours

    children 6 to 11 years

    take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours

    children under 6 years

    do not use
  • Other information

    •
    store at 15° to 30°C (59° to 86°F)
  • Inactive ingredients

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

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 71205-456-30

    Regular Strength

    Acetaminophen USP 325 mg

    PAIN RELIEVER

    FEVER REDUCER

    30 TABLETS

    *Compare to Active Ingredient in Regular Strength TYLENOL®

    71205-456-30
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 325 MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-456(NDC:69618-010)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AP;012
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-456-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2022
    2NDC:71205-456-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2022
    3NDC:71205-456-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2022
    4NDC:71205-456-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/01/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-456) , RELABEL(71205-456)
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