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IBUPROFEN 200MG 1000 TAB - 200 mg/1 TABLET, FILM COATED
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IBUPROFEN 200MG 1000 TAB

Generic: ibuprofen

IBUPROFEN 200MG 1000 TAB

NDC:57896-0941-10
Manufacturer:Geri-Care Pharmaceutical Corp
Strength:200 mg/1
Dosage Form:TABLET, FILM COATED
Route:ORAL

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Drug Information

Identification

Generic Name

ibuprofen

Brand Name

Ibuprofen

Labeler / Distributor

Geri-Care Pharmaceutical Corp

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

FDA Application Number

ANDA075010

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

Pharmacological Class

Anti-Inflammatory AgentsNon-Steroidal [CS]Cyclooxygenase Inhibitors [MoA]Nonsteroidal Anti-inflammatory Drug

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

Uses Temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis Temporarily reduces fever

Warnings

Warnings Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock hives facial swelling asthma (wheezing) skin reddening rash blisters If 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 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 surgery Ask a doctor before use if the 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 you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic Ask 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 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 faint -vomit blood -have bloody or black stools -have stomach pain that does not get better you have symptoms of heart problems or stroke: - chest pain - trouble breathing - leg swelling - slurred speech - weakness in one part or side of body pain gets worse or lasts more than 10 days redness or swelling is present in the painful area fever gets worse or lasts more than 3 days any new symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

Directions do not use more than directed the smallest effective dose should be used adults 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 take more than 6 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.