The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
- Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
- Skin reddeningblistersrashIf 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:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.
Otc - Purpose
Active ingredients (in each caplet)PurposesAcetaminophen 250 mgPain relieverIbuprofen 125 mg (NSAID
nonsteroidal anti-inflammatory drug)
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:
- Headachetoothachebackachemenstrual crampsmuscular achesminor pain of arthritis
Acetaminophen Liver Damage Warning
- This product contains acetaminophen. Severe liver damage may occur if you take:with other drugs containing acetaminophenmore than 6 caplets in 24 hours, which is the maximum daily amount for this product3 or more alcoholic drinks every day while using this product
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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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 pharmacistif you have ever had an allergic reaction to acetaminophen or any other pain relieverright before or after heart surgery
Ask A Doctor Before Use If
- You have liver diseasestomach bleeding warning applies to youyou have problems or serious side effects from taking pain relieversyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor's care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:
- Chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysredness or swelling is present in the painful areaany new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - 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.
Dosage & Administration
- Directionsdo not take more than directedadults and children 12 years and overtake 2 caplets every 8 hours while symptoms persist
- Children under 12 yearsask a doctordo not take more than 6 caplets in 24 hours, unless directed by a doctor
Storage And Handling
- Other informationread all warnings and directions before use. Keep carton.store at 20-25°C (68-77°F)avoid excessive heat above 40°C (104°F)
Inactive ingredientscarnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide
Otc - Questions
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