Drug Catalog - Product Detail
IBUPROFEN 800MG 500CT
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
65162-0466-50 | AMNEAL PHARMACEUTICALS | 500 | 800MG | TABLET |
PACKAGE FILES
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-1.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-1.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-2.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-2.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-3.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-3.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-4.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b266934-da61-4dc9-e063-6294a90a5445&name=ibuprofen-tablet---india-4.jpg)
Generic Name
IBUPROFEN
Substance Name
IBUPROFEN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078558
Description
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. 1
How Supplied
HOW SUPPLIED Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: Ibuprofen Tablets USP, 400 mg are 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 65162-464-03 Bottles of 60: NDC 65162-464-06 Bottles of 90: NDC 65162-464-09 Bottles of 100: NDC 65162-464-10 Bottles of 500: NDC 65162-464-50 Ibuprofen Tablets USP, 600 mg are 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 65162-465-03 Bottles of 50: NDC 65162-465-05 Bottles of 60: NDC 65162-465-06 Bottles of 90: NDC 65162-465-09 Bottles of 100: NDC 65162-465-10 Bottles of 500: NDC 65162-465-50 Ibuprofen Tablets USP, 800 mg are 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 65162-466-03 Bottles of 50: NDC 65162-466-05 Bottles of 60: NDC 65162-466-06 Bottles of 90: NDC 65162-466-09 Bottles of 100: NDC 65162-466-10 Bottles of 500: NDC 65162-466-50 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. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2022-06
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 ]. After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1200 mg to 3200 mg daily (400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond. In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis. The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg [See CLINICAL PHARMACOLOGY for effects of food on rate of absorption]. The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.