Label: ACETAMINOPHEN tablet

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

Drug Label Information

Updated January 8, 2024

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

  • Drug Facts

    Active ingredient (in each caplet)

    Acetaminophen USP 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •    temporarily relieves minor aches and pains due to:

        •    the common cold

        •    headache

        •    backache

        •    minor pain of arthritis

        •    toothache

        •    muscular aches

        •    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
    with other drugs containing acetaminophen
    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 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
  • 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

  • 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.

  • 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 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 over

    take 2 caplets every 6 hours while symptoms last
    do not take more than 6 caplets in 24 hours, unless directed by a doctor
    do not use for more than 10 days unless directed by a doctor

    children under 12 years

    ask a doctor

  • Other information

    store between 20° to 25°C (68° to 77°F)
    do not use if printed foil seal under cap is torn or missing.
  • Inactive ingredients

    povidone, pregelatinized starch (maize), stearic acid.

  • Questions or comments?

    call 1-855-274-4122

    Distributed by:
    Aurohealth LLC.
    279 Princeton- Hightstown Road,
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/16/2014

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)

    AUROHEALTH

    NDC 68788-8559-1
    Compare to the active ingredient
    in Tylenol ® Extra strength Caplets * 

    See New Warnings Information & Directions
    EXTRA STRENGTH
    For Adults
    Pain Relief
    Acetaminophen
    Caplets 500 mg
    Pain reliever/Fever reducer
    100 Caplets
    500 mg each
    Extra Strength APAP Tab 500mg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8559(NDC:58602-773)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
    Product Characteristics
    Colorwhite (White to off White) Scoreno score
    ShapeCAPSULE (Biconvex) Size18mm
    FlavorImprint Code N79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8559-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/08/2024
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8559)