Combogesic (Oral)

Ibuprofen and acetaminophen combination is used to relieve minor aches and pains such as headaches, backaches, toothaches, menstrual cramps, muscle aches, or arthritis pain.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that helps reduce inflammation, swelling, and pain in this combination.

Acetaminophen is used to relieve pain and lower fever in patients. It does not become habit-forming when taken for a long time. However, taking large doses of acetaminophen can cause unwanted effects, including serious liver damage.

This medicine is available as an over-the-counter (OTC) product.

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your or your child's symptoms do not improve for more than 10 days, or if they become worse, check with your doctor.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, NSAIDs, steroid, blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

This medicine may increase your risk of having a heart attack, heart failure, or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain or tightness, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medications. As well tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and acetaminophen combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of ibuprofen and acetaminophen combination in the elderly. However, elderly patients are more likely to develop age-related stomach issues, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially essential that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medications is not recommended. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medications is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Iloprost
• Imatinib
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Isoniazid
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine Sodium
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Polythiazide
• Potassium Citrate
• Pranoprofen
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this drug with any of the following medicines may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Acebutolol
• Acenocoumarol
• Amikacin
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carbamazepine
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Fosphenytoin
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Lixisenatide
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Phenytoin
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Using this drug with any of the following may cause an increased risk of certain adverse effects but may be unavoidable in some cases. If used together, your physician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you tell your clinician if you have any other medical issues, especially:

• Allergy to aspirin or
• Asthma or
• Heart attack, history of or
• Heart disease or
• High blood pressure, history of or
• Kidney disease or
• Liver disease (eg, cirrhosis) or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Heart surgery—Should not be used to ease pain right prior to or after the surgery.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blistering of the skin
• bloody or black, tarry stools
• chest pain or tightness
• confusion
• constipation
• cough
• decrease urine output
• diarrhea
• difficulty in speaking
• difficulty swallowing
• dilated neck veins
• dizziness
• double vision
• fast heartbeat
• headache
• heartburn
• hives, itching, skin rash
• inability to speak
• inability to move the arms, legs, or facial muscles
• indigestion
• irregular breathing
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin
• severe stomach pain, cramping, or burning
• swelling of the face, fingers, feet, or lower legs
• trouble breathing
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Combogesic

Available Dosage Forms:

• Tablet

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Large amounts of acetaminophen may cause liver damage if taken for a long time.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

You may take this medicine with milk or food to avoid stomach upset.

Do not drink 3 or more alcoholic drinks while you are using this medicine. Drinking alcoholic beverages while taking this medicine may increase your risk of liver damage and stomach bleeding.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For minor aches and pains: Adults and children 12 years of age and older—2 tablets every 8 hours as needed. Each tablet contains 250 milligrams (mg) acetaminophen and 125 mg ibuprofen. Do not take more than 6 tablets per day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.