Combogesic (Acetaminophen/ibuprofen Oral)

Generic name: Acetaminophen/ibuprofen
Drug class: Analgesic combinations

Usage of Combogesic (Acetaminophen/ibuprofen Oral)

Acetaminophen and ibuprofen combination is used for short-term management of mild to moderate pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage.

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

This medicine is available only with your doctor's prescription.

Combogesic (Acetaminophen/ibuprofen Oral) side effects

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

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

Incidence not known

Agitation

blistering, peeling, loosening of the skin

blood in the urine

bloody or black, tarry stools

blurred vision

changes in vision, especially night blindness

chest pain, discomfort, or tightness

chills

coma

confusion

constipation

cough

cracks in the skin

dark urine

decreased urine output

depression

difficulty in speaking

difficulty swallowing

dilated neck veins

dizziness

double vision

fast heartbeat

fever

glare or snowy image caused by bright light

headache

heartburn

hives, itching, skin rash

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

irritability

joint or muscle pain

lethargy

loss of appetite

loss of heat from the body

muscle twitching

nausea or vomiting

numbness or tingling in hands, feet, or lips

nervousness

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pale skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, swollen skin

red irritated eyes

red skin lesions, often with a purple center

scaly skin

seizures

slow or fast heartbeat

slow speech

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stiff neck or back

stomach pain, cramping, or burning

stupor

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weakness or heaviness of legs

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Trouble sleeping

Rare

Acid or sour stomach

belching

stomach discomfort or upset

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.

Before taking Combogesic (Acetaminophen/ibuprofen Oral)

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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 acetaminophen and ibuprofen combination in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen and ibuprofen combination in the elderly. However, elderly patients are more likely to develop age-related stomach, bowel, heart, or kidney problems, 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 medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines 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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor 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 medicines 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 medicines.

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 medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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 medicines 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 medicines may also 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 usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor 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

Relate drugs

How to use Combogesic (Acetaminophen/ibuprofen Oral)

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.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not drink 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 mild to moderate pain:

Adults—3 tablets every 6 hours as needed. Each tablet contains 325 milligrams (mg) acetaminophen and 97.5 mg ibuprofen. Do not take more than 12 tablets per day.

Children—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.

Warnings

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

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 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.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

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

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP) can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor immediately if blurred vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause aseptic meningitis. Check with your doctor right away if you have fever, headache, nausea, stiff neck or back, or vomiting.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

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

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