Label: ACETAMINOPHEN AND IBUPROFEN tablet

  • NDC Code(s): 0363-9131-16, 0363-9131-44
  • Packager: WALGREENS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2024

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  • Active Ingredients (in each caplet)
    Acetaminophen 250mg - Ibuprofen 125mg (NSAID)
  • Purposes
    Pain Reliever - Pain reliever
  • Uses
    ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache - ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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
    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose ...
  • Questions or comments?
    call - 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
  • PDP
    Dual action 144ct
  • PDP
    Dual action 216ct
  • INGREDIENTS AND APPEARANCE
    Product Information