Label: ACETAMINOPHEN AND IBUPROFEN tablet, film coated

  • NDC Code(s): 58602-893-01, 58602-893-03, 58602-893-07, 58602-893-11, view more
    58602-893-14, 58602-893-21, 58602-893-29, 58602-893-35, 58602-893-40, 58602-893-41, 58602-893-44, 58602-893-46, 58602-893-49, 58602-893-51, 58602-893-61, 58602-893-62, 58602-893-65, 58602-893-73, 58602-893-78, 58602-893-79, 58602-893-80, 58602-893-82, 58602-893-84, 58602-893-85, 58602-893-88, 58602-893-94, 58602-893-95, 58602-893-96, 58602-893-99
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 4, 2024

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

  • Drug Facts

    Active ingredients (in each caplet)                                                                             

    Acetaminophen USP 250 mg

    Ibuprofen USP 125 mg (NSAID*)

    *nonsteroidal anti-in­flammatory drug

  • Purposes

    Pain reliever

  • Uses

    • ­temporarily relieves minor aches and pains due to:­
      • headache
      • toothache
      • backache
      • menstrual cramps
      • muscular aches
      • minor pain of arthritis
  • Warnings

    Acetaminophen liver damage warning:

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

    • with other drugs containing acetaminophen ­
    • more than 6 caplets in 24 hours, which is the maximum daily amount for this product ­
    • 3 or more alcoholic drinks every day while using this product

    Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:­

    • skin reddening
    • ­blisters
    • rash ­

    If skin reaction occurs, stop use and seek medical help right away.

    NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling ­
    • asthma (wheezing) ­
    • shock ­
    • skin reddening ­
    • rash
    • blisters

     If an allergic reaction occurs, stop use and seek medical help right away.

    NSAID stomach bleeding warning:

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • ­are age 60 or older
    • have had stomach ulcers or bleeding problems ­
    • take a blood thinning (anticoagulant) or steroid drug ­
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ­
    • have 3 or more alcoholic drinks every day while using this product ­
    • take more or for a longer time than directed

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

  • 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 have ever had an allergic reaction to acetaminophen or any other pain reliever ­
    • ­right before or after heart surgery
  • Ask a doctor before use if

    • ­you have liver disease
    • stomach bleeding warning applies to you ­
    • you have problems or serious side effects from taking pain relievers ­
    • you have a history of stomach problems, such as heartburn ­
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ­
    • you are taking a diuretic
  • Ask a doctor or pharmacist before use if you are

    • ­under a doctor’s care for any serious condition­
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug
  • When using this product

    •    take with food or milk if stomach upset occurs

  • Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint ­
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • ­ you have symptoms of heart problems or stroke:
      • ­chest pain ­
      • trouble breathing
      • ­weakness in one part or side of body
      • ­slurred speech
      • ­leg swelling
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 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 ­

    adults and children 12 years and over
    • take 2 caplets every 8 hours while symptoms persist
    children under 12 years
    • ask a doctor

    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • Other information

    • read all warnings and directions before use.  Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • ­avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide

  • Questions or comments?

    Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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

    Made in India

    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Label)

    AUROHEALTH

    NDC 58602-893-03

    CONTAINS 2 MEDICINES
    Acetaminophen + Ibuprofen 

    Acetaminophen and Ibuprofen (NSAID)
    Tablets 250 mg/125 mg

    Pain Reliever

    10 Caplets*
    *Capsule-Shaped Tablets
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Carton Label)

    AUROHEALTH

    NDC 58602-893-03

     **Compare to the active ingredients of Advil
    Dual Action With Acetaminophen

    CONTAINS 2 MEDICINES
    Acetaminophen + Ibuprofen
     

    Acetaminophen and Ibuprofen (NSAID)
    Tablets 250 mg/125 mg

    Pain Reliever

    10 Caplets*
     *Capsule-Shaped Tablets
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Container Carton (10 Caplets)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 (1 x 2) Caplets)

    AUROHEALTH

    NDC 58602-893-61
                    
    **Compare to the active ingredients of Advil
    Dual Action With Acetaminophen

    CONTAINS 2 MEDICINES
    Acetaminophen + Ibuprofen
     

    Acetaminophen and Ibuprofen (NSAID)
    Tablets 250 mg/125 mg

    √    Headache                           √    Menstrual Cramps
    √    Muscular Aches                  √    Toothache
    √    Minor Pain of Arthritis

    Pain Reliever

    Each caplet contains Acetaminophen 250 mg
    and Ibuprofen 125 mg

    2 Caplets*
    *Capsule-Shaped Tablets
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 Caplets)

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND IBUPROFEN 
    acetaminophen and ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-893
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOW (Light Yellow to Yellow) Scoreno score
    ShapeCAPSULE (Biconvex) Size15mm
    FlavorImprint Code AI;II
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-893-031 in 1 CARTON03/26/2024
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-893-821 in 1 CARTON03/26/2024
    218 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-893-731 in 1 CARTON03/26/2024
    320 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-893-071 in 1 CARTON03/26/2024
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-893-111 in 1 CARTON03/26/2024
    536 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-893-141 in 1 CARTON03/26/2024
    650 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-893-651 in 1 CARTON03/26/2024
    772 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-893-211 in 1 CARTON03/26/2024
    8100 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:58602-893-291 in 1 CARTON03/26/2024
    9150 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:58602-893-62216 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    11NDC:58602-893-35225 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    12NDC:58602-893-44400 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    13NDC:58602-893-40500 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    14NDC:58602-893-88750 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    15NDC:58602-893-411000 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2024
    16NDC:58602-893-491 in 1 CARTON03/26/2024
    1610 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    17NDC:58602-893-461 in 1 CARTON03/26/2024
    1718 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    18NDC:58602-893-961 in 1 CARTON03/26/2024
    1820 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    19NDC:58602-893-011 in 1 CARTON03/26/2024
    1924 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    20NDC:58602-893-851 in 1 CARTON03/26/2024
    2036 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    21NDC:58602-893-781 in 1 CARTON03/26/2024
    2150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    22NDC:58602-893-801 in 1 CARTON03/26/2024
    2272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    23NDC:58602-893-941 in 1 CARTON03/26/2024
    23100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    24NDC:58602-893-51216 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2024
    25NDC:58602-893-84225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2024
    26NDC:58602-893-99400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2024
    27NDC:58602-893-79500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2024
    28NDC:58602-893-95750 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2024
    29NDC:58602-893-611 in 1 CARTON03/26/2024
    292 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21835903/26/2024
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-893) , MANUFACTURE(58602-893)