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 INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)**nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
Uses:temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor pain of arthritis• temporarily reduces fever
Warnings:Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.Symptoms may include:• hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach Bleeding Warning: This product contains a 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 presrciption 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 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: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgeryAsk a doctor before use if: • Stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a strokeAsk a doctor or pharmacist before use if you are: • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drugWhen using this product: • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directedStop use and ask a doctor if: • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear• you 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 better• you have symptoms of heart problems or stroke:• chst pain • trouble breathing •weakness in one part or side of body • slurred speech • leg swelling
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. (1-800-222-1222)
Dosage & Administration
Directions:• do not take more than directed• the smallest effective dose should be usedAdults and children 12 years and over: 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 of age: ask a doctor
Crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin* *contains one or more of these ingredients
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