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.
Otc - Active Ingredient
Active ingredientIbuprofen 200 mg (NSAID*).*nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducer
Indications & Usage
UsesTemporarily relieves minor aches and pains associated with■ headache ■ toothache ■ backache ■ menstrual cramps■ common cold ■ muscular aches ■ minor arthritis painTemporarily reduces fever.
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blistersIf an allergic reaction occurs, stop use and seek medical help right away.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 thinning (anticoagulant) or steroid drug■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)■ have 3 or more alcoholic drinks every day while using this product■ take more or for a longer time than directedHeart 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.
Otc - Do Not Use
- Do not useif you have evr had an allergic reaction to any other painb releiver/fever reducerright before or after heart surgery
Otc - Ask Doctor
- Ask a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to youyou 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
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you aretaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor’s care for any serious conditiontaking any other drug
Otc - When Using
- When using this product take with food or milk if stomach upset occurs
Otc - Stop Use
- Stop use and ask a doctor ifyou 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 betteryou have symptoms of heart problems or stroke • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swellingpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysredness or swelling is present in the painful areaany new or unexpected symptoms occur
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 specifically 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 use more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings)Adults and children: (12 years and older)Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
- Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
- Children under 12 years:Ask a doctor.
Other Safety Information
Other information■ read all product information before using■ store at 68-77°F (20-25°C)■ avoid excessive heat 104°F (above 40°C)■ tamper evident sealed packets■ do not use any opened or torn packets
Inactive ingredientscolloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol,
povidone (K-30), sodium starch glycolate, stearic acid, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-777-4908
* Please review the disclaimer below.