Label: ACETAMINOPHEN 500 MG- acetaminophen tablet

  • NDC Code(s): 69618-011-01, 69618-011-10
  • Packager: Reliable 1 Laboratories LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 31, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen USP, 500 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 and menstrual cramps

    • temporarily reduces fever
  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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 you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • STOP USE

    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 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 & children 12 years and over:

    • take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours

    children under 12 years: do not use

  • Other information

    • store at 15º to 30ºC (59º to 86ºF)
  • 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 69618-011-01

    Extra Strength

    Acetaminophen USP 500 mg

    PAIN RELIEVER

    FEVER REDUCER

    100 TABLETS

    *Compare to Active Ingredient in Extra Strength Tylenol®

    36961801101-ACETAMINOPHEN 500 MG TABLET -100

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500 MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AP;013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-011-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    2NDC:69618-011-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)