IBUPROFEN- ibuprofen tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reac

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white to off-white, oval, 'I 6' debossing on one side and plain on the other side) Bottles of 90; NDC68645-529-90 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) Bottles of 60; NDC 68645-530-59 800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side) Bottles of 30; NDC 68645-531-54 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF). Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Issued: June 2015 Distributed by: Wal-Mart Bentonville, AR 72716 Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) ___________________________________________________________________________________________________________________________________________________ What is the most important information I should know about medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at    1-800-FDA-1088. Other information about NSAIDs NSAID medicines requiring a prescription *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long-term continuous use may increase the risk of heart attack or stroke. The brands listed are the trademarks or register marks of their respective owners and are not trademarks of Granules India Limited. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Issued: June 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
IBUPROFEN TABLETS, USP
BOXED WARNING
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
Ibuprofen tablets are contraindicated for treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding,
ulceration, and perforation of the stomach or intestines, which can be
fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients are at greater risk
for serious gastrointestinal events (see WARNINGS).
DESCRIPTION
Ibuprofen tablets contain the active ingredient ibuprofen, which is
(±) -2 - (p - isobutylphenyl) propionic
acid. Ibuprofen is a white powder with a melting point of 74-77° C
and is very slightly soluble in water
(<1 mg/mL) and readily soluble in organic solvents such as ethanol and
acetone. The structural formula
is represented below:
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available
in 400 mg, 600 mg and 800 mg
tablets for oral administration. Inactive ingredients: colloidal
silicon dioxide, croscarmellose sodium,
hypromellose 2910, hydroxypropyl cellulose, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium
lauryl sulphate, titanium
dioxide.
CLINICAL PHARMACOLOGY
Ibuprofen tablets contain ibuprofen which possesses analgesic and
antipyretic activities. Its mode of
action, like that of other NSAIDs, is not completely understood, but
may be related to prostaglandin
synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, Ibuprofen t