IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, Inc.

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 Tablets. 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, Anaphylac

Product summary:

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: 400 mg white, round, biconvex, aqueous film-coated tablets, debossed "IP 464" on obverse and plain on reverse. They are available as follows: Bottles of 30:               NDC 53746-464-30    Bottles of 60:               NDC 53746-464-60    Bottles of 90:               NDC 53746-464-90 Bottles of 100:             NDC 53746-464-01    Bottles of 500:             NDC 53746-464-05 600 mg white, oval-shaped, biconvex, aqueous film-coated tablets, debossed "IP 465" on obverse and plain on reverse. They are available as follows: Bottles of 30:               NDC 53746-465-30    Bottles of 50:               NDC 53746-465-50    Bottles of 60:               NDC 53746-465-60 Bottles of 90:               NDC 53746-465-90    Bottles of 100:             NDC 53746-465-01    Bottles of 500:             NDC 53746-465-05 800 mg white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed "IP 466" on obverse and plain on reverse. They are available as follows: Bottles of 30:               NDC 53746-466-30    Bottles of 50:               NDC 53746-466-50    Bottles of 60:               NDC 53746-466-60 Bottles of 90:               NDC 53746-466-90    Bottles of 100:             NDC 53746-466-01    Bottles of 500:             NDC 53746-466-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Dispense in a tight, light-resistant container as defined in the USP. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 03-2019-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
IBUPROFEN TABLETS, USP
(400 MG, 600 MG AND 800 MG)
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can be
fatal. This risk may occur early in treatment and may increase with
duration of use
[see WARNINGS and PRECAUTIONS].
Ibuprofen Tablets are contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery [see CONTRAINDICATIONS and 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, USP contain the active ingredient ibuprofen, which
is (±)-2-(_p_-isobutylphenyl)
propionic acid. Ibuprofen is a white powder with a melting point of
74° to 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 Tablets, USP, 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, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
alcohol, pregelatinized starch, talc, stearic acid, and 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 tablets have been
shown