Label: AUROPHEN REGULAR STRENGTH- acetaminophen tablet

  • NDC Code(s): 58602-754-07, 58602-754-14, 58602-754-21
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • 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 and 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 of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours
    • 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 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 the user has

    liver disease

  • Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

  • 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 under 12 years
    • 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)
    Prompt 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 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
    children 6-11 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
    		ask a doctor

  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • do not use if carton is opened, or seal under cap is torn or missing.
  • Inactive ingredients

    colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, sodium starch glycolate, talc

  • Questions or comments?

    1-855-274-4122

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    Distributed by:Aurohealth LLC.
    2572 Brunswick Pike, Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle)

    AUROHEALTH

    NDC 58602-754-21

    Compare to the active ingredient in Tylenol ®Regular Strength tablets *
    See Warnings Information & Directions
    REGULAR STRENGTH
    AUROPHEN
    Acetaminophen Tablets 325 mg
    Pain reliever/Fever reducer
    100 Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROPHEN REGULAR STRENGTH 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (White to off White) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code N74
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-754-071 in 1 CARTON02/26/2016
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-754-141 in 1 CARTON02/26/2016
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-754-211 in 1 CARTON02/26/2016
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/26/2016
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777manufacture(58602-754)
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