Label: ACETAMINOPHEN 325 MG- acetaminophen tablet

  • NDC Code(s): 69618-010-01, 69618-010-10
  • Packager: Reliable 1 Laboratories LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2025

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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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • Directions
    do not take more than directed (see overdose warning) adults and children 12 years and overtake 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 ...
  • 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 - www.reliable1labs.com
  • PRINCIPAL DISPLAY PANEL
    NDC 69618-010-01 - Regular Strength - Acetaminophen USP 325 mg - PAIN RELIEVER - FEVER REDUCER - 100 TABLETS - *Compare to Active Ingredient in Regular Strength TYLENOL®
  • INGREDIENTS AND APPEARANCE
    Product Information