Acetaminophen-Ibuprofen

Acetaminophen-Ibuprofen is a combination of over-the-counter (OTC) medications used for treating pain and aches.

• Acetaminophen-Ibuprofen is available under the following different brand names: Advil Dual Action.

Adult and pediatric dosage

Tablet

• 250 mg /125 mg

Pain

Adult dosage

• 2 tablets orally every 8 hours while symptoms persist; not to exceed 6 tablets/day, unless directed by the physician

Maximum dose

• Acetaminophen containing products: Not to exceed a cumulative dose of 3.25 g / day of acetaminophen; under the supervision of a healthcare professional, daily doses of up to 4 g/day may be used

Pediatric dosage

• Children below 12 years: Safety and efficacy not established
• Children above 12 years: 2 tablets orally every 8 hours while symptoms persist; not to exceed 6 tablets/day, unless directed by the physician

Maximum dose

• Acetaminophen containing products: Not to exceed a cumulative dose of 3.25 g / day of acetaminophen; under the supervision of a healthcare professional, daily doses of up to 4 g / day may be used

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Acetaminophen-Ibuprofen include:

• upset stomach, 
• nausea,
• vomiting, 
• headache,
• diarrhea, 
• constipation, 
• dizziness, or
• drowsiness.

Serious side effects of the Acetaminophen-Ibuprofen include:

• easy bruising/bleeding,
• hearing changes (such as ringing in the ears),
• difficult/painful swallowing, 
• mental/mood changes, 
• vision changes, 
• signs of kidney problems (such as a change in the amount of urine), 
• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Rare side effects of the Acetaminophen-Ibuprofen include:

• liver disease

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acetaminophen-Ibuprofen has severe interactions with no other drugs.
• Acetaminophen-Ibuprofen has serious interactions with at least 29 other drugs.
• Acetaminophen-Ibuprofen has moderate interactions with at least 267 other drugs.
• Acetaminophen-Ibuprofen has minor interactions with at least 143 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Ibuprofen
• Hypersensitivity to ibuprofen, other NSAIDs, aspirin, or excipients
• Perioperative pain in the setting of CABG surgery
• Acetaminophen
• Hypersensitivity
• Severe active liver disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Ibuprofen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Ibuprofen?”

Cautions

Acetaminophen

• Hepatotoxicity risk
• The risk of hepatotoxicity is higher in patients taking long-term high doses, or use of more than one acetaminophen-containing product
• Acetaminophen is available in many dosage forms and products; check the label carefully to avoid overdose
• Limit acetaminophen dose from all sources and routes to less than 4 g/day in adults
• Consumption of 3 or more alcoholic drinks/per day may increase the risk of liver damage

Allergic reaction

• Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; symptoms may include skin redness, blisters, and rash
• Discontinue if symptoms occur and seek medical help immediately

Ibuprofen

• If pregnant or breastfeeding, ask a health professional before use; it is essential not to use ibuprofen at 20 weeks or later in pregnancy unless directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery
• 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

NSAID allergy

• May cause a severe allergic reaction, especially in patients allergic to aspirin
• Symptoms may include hives, asthma, skin redness, blisters, rash, facial swelling, and shock
• Discontinue if symptoms occur and seek medical help immediately

GI bleeding

• NSAIDs increase the risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
• The risk is higher with patients who are aged above 60 years, have a history of peptic ulcer disease or GI bleeding, take anticoagulants or corticosteroids, take aspirin or other NSAIDs, consume more than 3 alcoholic drinks every day while taking this drug, or take a higher dose or for a longer duration than recommended

Cardiovascular risk

• NSAIDs, except aspirin, increase the risk of MI, heart failure, and stroke, which can be fatal
• Higher risk if higher dose consumed or taken longer than directed

Renal injury

• Long-term administration of NSAIDs may result in renal papillary necrosis and another renal injury
• Patients at greatest risk include elderly individuals and those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion
• Risk increased if coadministered with diuretics, ACE inhibitors, or angiotensin receptor blockers

Pregnancy and Lactation

Ibuprofen

• Ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery; NSAID use during the third trimester increases the risk of premature closure of the fetal ductus arteriosus
• There are no adequate and well-controlled studies on pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

Acetaminophen

• Low risk of cryptorchidism in boys if used for several weeks or longer

Lactation

Ibuprofen

• Considered compatible with breastfeeding (LactMed)
• No lactation studies have been conducted; however, limited published literature reports that following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose

Acetaminophen

• Considered compatible with breastfeeding (LactMed)